FDA Adverse Event Malfunction Summary report: N

ENDURANT

MDR report key: 2883376 · Received December 21, 2012

Report

Report Number: 2953200-2012-02456
Event Type: Malfunction
Date Received: December 21, 2012
Date of Event: November 26, 2012
Report Date: November 26, 2012
Manufacturer: MEDTRONIC IRELAND
Product Code: MIH
PMA / PMN Number: P100021
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). RESULTS: INHERENT RISK OF PROCEDURE (KINK); CAUSED BY ANOTHER DRUG/DEVICE (BARE METAL STENT). CONCLUSION: ANOTHER DEVICE CAUSED FAILURE (BARE METAL STENT).

Description of Event or Problem · 1

AN ENDURANT STENT GRAFT SYSTEM WAS SELECTED FOR USE IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 4.2 CM ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL AORTIC NECK WAS 21-24 MM IN DIAMETER AND 24 MM IN LENGTH. THE RIGHT ILIAC ARTERY WAS 14, 8 MM IN DIAMETER. THE LEFT ILIAC ARTERY WAS 18, 17 MM IN DIAMETER. THE RIGHT AND LEFT FEMORAL ARTERIES WERE 8 MM IN DIAMETER. IT WAS REPORTED THAT THE DEVICE WAS PREPPED AS USUAL. THE RIGHT INTERNAL ILIAC ARTERY WAS COILED. THE GUIDE WIRE WAS INSERTED FROM RIGHT FEMORAL ARTERY FOR PULL THROUGH PURPOSE. THE ENDURANT STENT GRAFT WAS INSERTED, USING GREATER FORCE THAN ANTICIPATED, FROM RIGHT FEMORAL ARTERY; HOWEVER THE DELIVERY SYSTEM CAUGHT ON A PREVIOUSLY IMPLANTED; BARE METAL STENT SO BALLOONING WAS DONE, BUT COULD NOT DELIVER THE DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS REMOVED AND THE CASE WAS ABORTED. UPON REMOVAL IT WAS NOTED THAT THE DELIVERY SYSTEM HAD A SLIGHT KINK. THE PHYSICIAN ATTEMPTED TO STRAIGHTEN; HOWEVER, WAS UNABLE TO DO SO. THE PHYSICIAN WILL MONITOR THE PATIENT. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDURANT	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	MEDTRONIC IRELAND		V01130018

Patients

Seq	Age	Sex	Outcome	Treatment
1	00081 YR