FDA Adverse Event Injury Summary report: N

ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

MDR report key: 5456351 · Received February 24, 2016

Report

Report Number: 3001845648-2016-00045
Event Type: Injury
Date Received: February 24, 2016
Date of Event: January 20, 2016
Report Date: February 24, 2016
Manufacturer: COOK IRELAND LTD
Product Code: NIU
UDI-DI: 10827002353104
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PMA/510(K): P100022/S014. THE INVESTIGATION OF THIS EVENT IS STILL BEEN CARRIED OUT. A FOLLOW UP REPORT WILL BE SUBMITTED WITHIN 30 DAYS WITH THE INVESTIGATION CONCLUSIONS.

Additional Manufacturer Narrative · 1

PMA/510(K): P100022/S014. IMAGES RELATING TO THIS EVENT HAVE RECENTLY BEEN RECEIVED AND ARE CURRENTLY BEING REVIEWED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE IMAGE REVIEW DETAILS AND FINAL INVESTIGATION CONCLUSIONS.

Description of Event or Problem · 1

INFORMATION RECEIVED INDICATES THROMBOLYSIS WAS CARRIED OUT AFTER ZILVER PTX STENT PLACEMENT. ALTHOUGH REQUESTED NO FURTHER DETAILS OR CLARIFICATION HAS BEEN RECEIVED RELATING TO THIS EVENT.

Description of Event or Problem · 1

IMAGES RELATING TO THIS EVENT HAVE RECENTLY BEEN RECEIVED AND ARE CURRENTLY BEING REVIEWED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE IMAGE REVIEW DETAILS AND FINAL INVESTIGATION CONCLUSIONS. INITIAL EVENT DESCRIPTION SUBMITTED AS FOLLOWS: INFORMATION RECEIVED INDICATES THROMBOLYSIS WAS CARRIED OUT AFTER ZILVER PTX STENT PLACEMENT. ALTHOUGH REQUESTED NO FURTHER DETAILS OR CLARIFICATION HAS BEEN RECEIVED RELATING TO THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
114478	ZILVER PTX DRUG-ELUTING PERIPHERAL STENT	NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING	NIU	COOK IRELAND LTD			10827002353104

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention