VALIANT CAPTIVIA THORACIC STENT GRAFT SYSTEM

MDR report key: 2920628 · Received January 17, 2013

Report

Report Number: 2953200-2013-00095
Event Type: Injury
Date Received: January 17, 2013
Date of Event: December 1, 2012
Report Date: December 19, 2012
Manufacturer: MEDTRONIC IRELAND
Product Code: MIH
PMA / PMN Number: P100040
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (PARALYSIS).

Description of Event or Problem · 1

A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 57.8 MM DIAMETER X 210 MM LENGTH THORACIC AORTIC ANEURYSM APPROXIMATELY ONE MONTH AGO. THE DISTAL DIAMETER OF THE PROXIMAL AORTIC NECK WAS 36.5 MM. THE RIGHT COMMON ILIAC WAS 7.8 MM IN DIAMETER. THE LEFT COMMON ILIAC WAS 7 MM IN DIAMETER. THERE WAS MINOR THROMBUS DISTAL TO THE LSA AND SIGNIFICANT AORTIC TORTUOSITY. A VALIANT VAMF4242C200TUAND A VAMC3636C150TU WERE SUCCESSFULLY IMPLANTED. IT WAS REPORTED THAT THE CASE WENT WELL WITH A GOOD RESULT; HOWEVER, THE PATIENT BECAME PARALYZED AND IS UNDERGOING REHABILITATION (EXACT DATE OF THE EVENT IS UNKNOWN). THE PATIENT HAD A SPINAL DRAIN PLACED FOR THIS PROCEDURE AND THE STENT GRAFT COVERAGE WAS IN THE PROXIMAL 2/3 OF THE DESCENDING AORTA WITHOUT COVERAGE OF THE LSA. THE PATIENT EXPERIENCED DECREASED ABILITY WHEN THE SPINAL PRESSURE WAS ALLOWED TO RETURN TO NORMAL. THE PHYSICIAN DECIDED TO PULL THE SPINAL DRAIN REGARDLESS. NO FURTHER INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
26342	VALIANT CAPTIVIA THORACIC STENT GRAFT SYSTEM	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	MEDTRONIC IRELAND		V01053793

Patients

Seq	Age	Sex	Outcome	Treatment
1	64 YR		Required Intervention