FDA Adverse Event Malfunction Summary report: N

ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL EXTENSION

MDR report key: 6334893 · Received February 16, 2017

Report

Report Number: 3002808486-2017-00471
Event Type: Malfunction
Date Received: February 16, 2017
Date of Event: May 28, 2014
Report Date: May 28, 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: BASED ON THE ABOVE INFORMATION IT IS NOT POSSIBLE TO CONCLUDE THE EXACT ROOT CAUSE FOR THIS EVENT. IT IS HOWEVER CONSIDERED MOST LIKELY THAT THE ADVANCEMENT DIFFICULTIES IN "SEVERE CURVED ANATOMY" CAUSED DIFFICULTIES IN ADVANCING THE INTRODUCER SYSTEM. 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: AT AN URGENT TEVAR WITH PERFORMING A BYPASS OF THE LEFT SUBCLAVIAN ARTERY FOR RUPTURED TAA, THE USER PLACED A MAINBODY WITH USING PULL-THROUGH TECHNIQUE DUE TO STRONGLY CURVED AORTA ARCH. NO ENDOLEAK WAS CONFIRMED BUT HE ATTEMPTED TO PLACE A ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL EXTENSION IN CASE. HOWEVER, THE DELIVERY SYSTEM WOULD NOT PASS THE OUTER CURVATURE OF THE AORTA ARCH. THE PROCEDURE WAS COMPLETED WITHOUT PLACING AN EXTENSION. PATIENT OUTCOME: THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
118277	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