IN.PACT Admiral FDA Alert

The FDA just lit you guys up! It sure has been a rough couple of weeks for Medtronic.

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MEDTRONIC IRELAND IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETERBack to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/22/2018
Event Type Injury
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Approximately 54 months post index procedure the patient underwent revascularization of target lesion with three in pact admiral debs. Approximately 5 months post revascularization the patient suffered restenosis of the right sfa. The patient discontinued from study participation. Cec adjudicated the event as related to the index device and not related to the index procedure or paclitaxel. Cec adjudicated the event as a target lesion percutaneous revascularization; clinically driven.

Manufacturer Narrative

Additional information reported that no tlr was carried out to treat this ae. The lot numbers of the devices used are not available. If information is provided in the future, a supplemental report will be issued.

These results have been known about for a while and hasn't changed usage in my region at all. Much to do about nothing.

post

It’s fair to point out that this affects multiple companies, not just Medtronic.

Yes, there are others but....

MEDTRONIC IRELAND IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETERBack to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/22/2018
Event Type Injury
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Approximately 54 months post index procedure the patient underwent revascularization of target lesion with three in pact admiral debs. Approximately 5 months post revascularization the patient suffered restenosis of the right sfa. The patient discontinued from study participation. Cec adjudicated the event as related to the index device and not related to the index procedure or paclitaxel. Cec adjudicated the event as a target lesion percutaneous revascularization; clinically driven.

Manufacturer Narrative

Additional information reported that no tlr was carried out to treat this ae. The lot numbers of the devices used are not available. If information is provided in the future, a supplemental report will be issued.

post

It’s fair to point out that this affects multiple companies, not just Medtronic.

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