OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

MDR report key: 5040356 · Received August 28, 2015

Report

Report Number: 3008011247-2015-00098
Event Type: Malfunction
Date Received: August 28, 2015
Date of Event: July 31, 2015
Report Date: July 31, 2015
Manufacturer: TRIVASCULAR, INC.
Product Code: MIH
PMA / PMN Number: P120006
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IT
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

REMAINS IMPLANTED.

Description of Event or Problem · 1

AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. PRIOR TO FILLING THE STENT GRAFT, THE FILL POLYMER LIQUID FROM THE TO KITS WITH A LEAK AT THE STOPCOCK COMPONENT WAS MIXED AND INJECTED INTO THE AORTIC BODY STENT GRAFT. UPON DEMATE OF THE AORTIC BODY DELIVERY SYSTEM, THE FILL POLYMER MATERIAL IN THE STENT GRAFT EMPTIED THROUGH THE FILL TUBE AND A TYPE IA ENDOLEAK WAS OBSERVED ON THE FINAL ANGIOGRAM WHICH COULD NOT BE RESOLVED FOLLOWING THE IMPLANTATION OF AN AORTIC CUFF. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED AND THE PATIENT WILL CONTINUE TO BE MONITORED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
573285	OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM	ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM	MIH	TRIVASCULAR, INC.	TV-AB2980-D	FS022515-41

Patients

Seq	Age	Sex	Outcome	Treatment
1	80 YR		Other