FDA Adverse Event Malfunction Summary report: N

ZENITH® TX2® TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT

MDR report key: 6348577 · Received February 22, 2017

Report

Report Number: 3002808486-2017-00580
Event Type: Malfunction
Date Received: February 22, 2017
Date of Event: August 26, 2014
Report Date: August 26, 2014
Manufacturer: WILLIAM COOK EUROPE
Product Code: MIH
UDI-DI: 10827002236148
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). SIMILAR TO DEVICE UNDER 510(K) P070016. SUMMARY OF INVESTIGATIONAL FINDINGS: PRODUCT WAS RETURNED TO AID THE INVESTIGATION. EXAMINATION OF THE HANDLE FOUND TWO MARKS, THIS SUGGEST THAT GREEN KNOB WAS ROTATED, WHICH CAN CAUSE THE WIRES TO BE CAUGHT BETWEEN THE HANDLE AND THE RELEASE KNOB. THIS WILL PROVIDE ADDITIONAL FRICTION TO THE WIRES. BASED ON THE FINDINGS THE ROOT CAUSE OF THIS EVENT MAY BE RELATED TO ROTATION OF THE GREEN KNOB DURING DEPLOYMENT. NO EVIDENCE TO SUGGEST THAT THIS DEVICE 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: TRIGGER WIRES DURING DEPLOYMENT OF GRAFT WERE EXTREMELY STIFF AND DIFFICULT TO RETRIEVE WITHOUT EXCESSIVE FORCE. PHYSICIAN NOTED THIS IS THE SECOND CONSECUTIVE OCCURRENCE AND WOULD LIKE AN INVESTIGATION INTO THE CAUSE. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
132471	ZENITH® TX2® TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT	MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	WILLIAM COOK EUROPE			10827002236148

Patients

Seq	Age	Sex	Outcome	Treatment
1