FDA Adverse Event Malfunction Summary report: N

ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL EXTENSION

MDR report key: 6334900 · Received February 16, 2017

Report

Report Number: 3002808486-2017-00472
Event Type: Malfunction
Date Received: February 16, 2017
Date of Event: November 20, 2014
Report Date: November 21, 2014
Manufacturer: WILLIAM COOK EUROPE
Product Code: MIH
UDI-DI: 10827002526546
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). SIMILAR TO DEVICE UNDER 510(K) P070016. SUMMARY OF INVESTIGATIONAL FINDINGS: NO EXACT ROOT CAUSE WAS FOUND IN THIS INVESTIGATION. HOWEVER STRONGLY CURVED ANATOMY COULD HAVE BEEN A CONTRIBUTING FACTOR IN THE ADVANCEMENT DIFFICULTIES EXPERIENCED. NO EVIDENCE TO SUGGEST THAT PRODUCT WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

Description of Event or Problem · 1

DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THIS PATIENT WAS IMPLANTED ZENITH AAA ( TFB-32-?-(B)(4)) FEW YEARS AGO. THE PHYSICIAN CONFIRMED PROXIMAL TYPE I ENDOLEAK FROM A ZENITH PRODUCT IMPLANTED PREVIOUSLY. TO TREAT THE ENDOLEAK, THE PHYSICIAN INSERTED AND ADVANCED THE DELIVERY SYSTEM BUT IT WOULD NOT PASS A TORTUOUS PART OF THE AORTA. HE GAVE UP USING AND REPLACED IT WITH GORE¿S C-TAG, AND IT WAS SUCCESSFULLY PLACED ON THE PROXIMAL SITE OF ZENITH AAA. THEREFORE, THE ENDOLEAK WAS RESOLVED AND COMPLETED THE PROCEDURE. THIS DEVICE USED FOR THE REPAIRING OF ZENITH AAA, SO IT SEEMS NOT SUITABLE FOR TX2. PATIENT OUTCOME: UNKNOWN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
118286	ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL EXTENSION	MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	WILLIAM COOK EUROPE			10827002526546

Patients

Seq	Age	Sex	Outcome	Treatment
1