FDA Adverse Event Injury Summary report: N

OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

MDR report key: 5072940 · Received September 11, 2015

Report

Report Number: 3008011247-2015-00101
Event Type: Injury
Date Received: September 11, 2015
Date of Event: August 6, 2015
Report Date: August 13, 2015
Manufacturer: TRIVASCULAR, INC.
Product Code: MIH
PMA / PMN Number: P120006
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

BASED ON A REVIEW OF THE 1 MONTH POST-OPERATIVE CT, THE REPORTED ENDOLEAK WAS CONFIRMED TO BE A TYPE II ENDOLEAK FROM PATENT LUMBAR VESSELS AT THE DISTAL END OF THE AORTIC BODY GRAFT LEGS; THERE WAS NO EVIDENCE OF A TYPE III ENDOLEAK. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. DEVICE REMAINS IMPLANTED.

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. THE FINAL ANGIOGRAM SHOWED THE PRESENCE OF A POTENTIAL TYPE III ENDOLEAK NEAR THE JUNCTION OF THE AORTIC BODY AND ILIAC LIMB STENT GRAFTS THAT COULD NOT RESOLVED FOLLOWING THE PLACEMENT OF A BALLOON EXPANDABLE STENT. BASED ON A REVIEW OF THE INTRAOPERATIVE IMAGING BY TRIVASCULAR, IT COULD NOT BE DETERMINED IF THE ENDOLEAK IS A TYPE III OR A TYPE II FROM A PATENT LUMBAR VESSELS ENTERING THE ANEURYSM SAC AT THE SAME LEVEL. 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
602380	OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM	ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM	MIH	TRIVASCULAR, INC.	TV-AB2980-E	FS040115-30

Patients

Seq	Age	Sex	Outcome	Treatment
1	100 YR		Other