FDA Adverse Event Injury Summary report: N

ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO

MDR report key: 1911059 · Received November 24, 2010

Report

Report Number: 2953200-2010-02339
Event Type: Injury
Date Received: November 24, 2010
Date of Event: October 27, 2010
Report Date: October 27, 2010
Manufacturer: MEDTRONIC CARDIOVASCULAR GALWAY
Product Code: MIH
PMA / PMN Number: P990020
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). EVAL, RESULTS: AORTIC PERFORATION. PRE-OPERATIVE RUPTURED ANEURYSM, DISEASED AND WEAK AND AORTA. EVAL, CONCLUSIONS: PRE-OPERATIVE RUPTURED ANEURYSM, DISEASED AND WEAK AND AORTA.

Description of Event or Problem · 1

AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PT PRESENTED TO THE ER WITH A PRE-OPERATIVE RUPTURED ANEURYSM (DIAMETER IS UNK). THE AORTA WAS VERY DISEASED AND WEAK. THE BIFURCATED STENT WAS SUCCESSFULLY IMPLANTED. THE CUFF WAS IMPLANTED BECAUSE THERE WAS A LARGE PROXIMAL TYPE 1 ENDOLEAK; HOWEVER, THE ENDOLEAK DID NOT RESOLVE AND THE PHYSICIAN COULD NOT TELL WHERE IT WAS COMING FROM. THE DECISION WAS MADE TO EXPLANT ALL THE STENT GRAFTS AND SEW IN A DACRON GRAFT. DURING THE EXPLANT, IT WAS NOTED THAT THE ENDOLEAK WAS COMING FROM A HOLE IN THE AORTA ABOVE THE RENAL ARTERIES. IT IS UNK WHEN THIS HAPPENED, BUT THE PHYSICIAN THINKS HE MAY HAVE PERFORATED THE AORTA WITH THE WIRE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE. (REF. MFR 2953200-2010-02338).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO		MIH	MEDTRONIC CARDIOVASCULAR GALWAY	NA	V00421424

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Required Intervention