FDA Adverse Event Injury Summary report: N

ANEURX ABDOMINAL STENT GRAFT SYSTEM

MDR report key: 2914505 · Received January 14, 2013

Report

Report Number: 2953200-2013-00087
Event Type: Injury
Date Received: January 14, 2013
Date of Event: December 16, 2012
Report Date: December 16, 2012
Manufacturer: MEDTRONIC CARDIOVASCULAR
Product Code: MIH
PMA / PMN Number: P990020
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NV, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (STENT GRAFT MIGRATION, ENDOLEAK, ANEURYSM RUPTURE). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (DISEASE PROGRESSION). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (DISEASE PROGRESSION).

Description of Event or Problem · 1

AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 55 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT ARE UNKNOWN. THE PATIENT HAS HAD 2 FOLLOW-UPS SINCE THE TIME OF IMPLANT. CURRENTLY THE ANEURYSM MEASURES 9 CM IN DIAMETER. THE VESSELS WERE NON-TORTUOUS AND NON-CALCIFIED. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED ANEURYSM. THE STENT GRAFT HAS MIGRATED 3-3.5 CM BELOW THE LOWEST RENAL ARTERY WITH A PROXIMAL TYPE I ENDOLEAK PRESENT. THE DISTAL AORTIC NECK MEASURED 30 MM IN DIAMETER AND DIRECTLY BELOW THE RENAL IT WAS 27 MM IN DIAMETER. THE MIGRATION AND ENDOLEAK WERE DUE TO NECK DILATATION. AN ENDURANT CUFF 36X36X70 WAS SUCCESSFULLY PLACED RESOLVING THE ENDOLEAK. THE PATIENT IS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
20387	ANEURX ABDOMINAL STENT GRAFT SYSTEM	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	MEDTRONIC CARDIOVASCULAR		V00104374

Patients

Seq	Age	Sex	Outcome	Treatment
1	00092 YR		Required Intervention