FDA Adverse Event Injury Summary report: N

ANEURX STENT GRAFT SYSTEM

MDR report key: 2761147 · Received September 26, 2012

Report

Report Number: 2953200-2012-01859
Event Type: Injury
Date Received: September 26, 2012
Date of Event: August 30, 2012
Report Date: August 30, 2012
Manufacturer: MEDTRONIC CARDIOVASCULAR SANTA ROSA
Product Code: MIH
PMA / PMN Number: P990020
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK), INCORRECT TECHNIQUE/PROCEDURE (MINIMAL OVERLAP OF STENT GRAFTS). CONCLUSION: OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (MINIMAL OVERLAP OF STENT GRAFTS).

Description of Event or Problem · 1

AN ANEURX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM, AP PROXIMATELY EIGHT YEARS AGO. ANEURYSM SIZE FROM THE TIME OF IMPLANT IS UNKNOWN. IT WAS REPORTED THAT DURING A ROUTINE CT SCAN REVIEW, THE STENT GRAFT WAS FOUND TO HAVE MIGRATED APPROXIMATELY 2 CM DISTALLY. THERE WAS ALSO A TYPE III ENDOLEAK, SEPARATION BETWEEN THE CONTRALATERAL LIMB AND THE CONTRALATERAL GATE DUE TO MINIMAL OVERLAP AT THIS AREA. THERE WERE TWO (B)(4) ILIAC LIMBS THAT WERE ORIGINALLY IMPLANTED; HOWEVER, IT IS UNKNOWN WHICH ONE WAS THE CONTRALATERAL LIMB. THE PHYSICIAN ELECTED TO IMPLANT AN ANEURX ILIAC LIMB AND SUCCESSFULLY RESOLVED THE TYPE III ENDOLEAK, SEPARATION. THE MIGRATION WAS NOT ADDRESSED AS THERE WAS NO ENDOLEAK. THE PATIENT WILL CONTINUE TO BE MONITORED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ANEURX STENT GRAFT SYSTEM	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	MEDTRONIC CARDIOVASCULAR SANTA ROSA		M03J550231

Patients

Seq	Age	Sex	Outcome	Treatment
1	00070 YR		Required Intervention