ANEURX

MDR report key: 3971889 · Received July 31, 2014

Report

Report Number: 2953200-2014-01496
Event Type: Malfunction
Date Received: July 31, 2014
Date of Event: July 9, 2014
Report Date: July 9, 2014
Manufacturer: MEDTRONIC CARDIOVASCULAR
Product Code: MIH
PMA / PMN Number: P990020
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPH OLOGY IS UNKNOWN. IT WAS REPORTED THAT THE PATIENT WAS IN FOR A ROUTINE SIX YEAR FOLLOW UP. IT WAS NOTED THAT THE STENT GRAFT HAD MIGRATED 15MM WITH NO SIGNS OF AN ENDOLEAK AT THE AORTIC NECK. HOWEVER, THERE WAS A TYPE IB ENDOLEAK. THE PATIENT HAD A LARGE ILIAC ARTERY MEASURING 3.6 CM. THE PHYSICIAN DECIDED TO EMBOLIZE THE HYPOGASTRIC ON THE RIGHT SIDE AND EXTEND THE GRAFT WITH A 16X13X199, THE ENDOLEAK RESOLVED. THE MIGRATION HAS NOT BEEN TREATED. THE PHYSICIAN WILL MONITOR THE PATIENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
446561	ANEURX	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	MEDTRONIC CARDIOVASCULAR		V00072118

Patients

Seq	Age	Sex	Outcome	Treatment
1	00079 YR