FDA Adverse Event Injury Summary report: N

TALENT

MDR report key: 3091940 · Received May 3, 2013

Report

Report Number: 2953200-2013-00818
Event Type: Injury
Date Received: May 3, 2013
Date of Event: April 9, 2013
Report Date: April 9, 2013
Manufacturer: MEDTRONIC IRELAND
Product Code: MIH
PMA / PMN Number: P070027
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

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

Description of Event or Problem · 1

A TALENT STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY IS UNKNOWN. IT WAS REPORTED THAT THE PATIENT WAS IN FOR A ROUTINE FOLLOW UP AND A MIGRATION RESULTING IN A PROXIMAL TYPE I ENDOLEAK WAS NOTED DUE TO DISEASE PROGRESSION. SIXTEEN DAYS LATER, THE PATIENT HAD A SECONDARY PROCEDURE. A MODIFIED 42X42X100 VALIANT PROXIMAL MAIN WAS PLACED FROM A CUT DOWN ON THE RIGHT GROIN. THE PHYSICIAN PLACED THE STENT GRAFT JUST BELOW THE SMA. THE PHYSICIAN ALSO PLACED BARE METAL STENTS IN TO SNORKEL BOTH RENAL ARTERIES. A CUT DOWN ON THE LEFT BRACHIAL ARTERY WAS DONE. THE PHYSICIAN PLACED TWO 7 FRENCH SHEATHS IN BOTH RENAL ARTERIES. THERE WAS NO EVIDENCE OF A TYPE I ENDOLEAK ON THE FINAL ANGIOGRAM. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
194234	TALENT	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	MEDTRONIC IRELAND		V00382463

Patients

Seq	Age	Sex	Outcome	Treatment
1	00079 YR		Required Intervention