FDA Adverse Event Injury Summary report: N

TALENT

MDR report key: 3187337 · Received June 25, 2013

Report

Report Number: 2953200-2013-01184
Event Type: Injury
Date Received: June 25, 2013
Date of Event: April 11, 2011
Report Date: May 27, 2013
Manufacturer: MEDTRONIC IRELAND
Product Code: MIH
PMA / PMN Number: P070007
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). RESULTS: ENDOLEAK. LACK OF INFORMATION, CAUSE OF EVENT IS UNKNOWN. CONCLUSION: LACK OF INFORMATION, CAUSE OF EVENT IS UNKNOWN. ENDOLEAK.

Description of Event or Problem · 1

A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A SACCULAR 53 MM IN DIAMETER AND 20 MM IN LENGTH THORACIC AORTIC ANEURYSM. THE PROXIMAL NECK WAS 29 MM IN DIAMETER. THE COMMON ILIAC ARTERY WAS MILDLY CALCIFIED. A CT SHOWED THE ANEURYSM AT 60 MM IN DIAMETER DUE TO A TYPE IA ENDOLEAK. A YEAR LATER THE CT SHOWED THE ANEURYSM AT 68 MM IN DIAMETER AND IT WAS CONFIRMED THAT THE ENDOLEAK WAS RESIDUAL. THE FOLLOWING YEAR THE ANEURYSM DIAMETER HAD EXPANDED, THE PATIENT WAS TREATED WITH A VALIANT STENT GRAFT ON THE PROXIMAL SIDE OF THE 3232, HOWEVER, THE ENDOLEAK DID NOT RESOLVE. THEREFORE, ANOTHER VALIANT STENT GRAFT WAS IMPLANTED ON THE PROXIMAL SIDE OF 3232200. WHEN THE DEVICES WERE IMPLANTED, A CHIMNEY TECHNIQUE WAS ALSO PERFORMED TO SAVE THE LEFT COMMON CAROTID ARTERY. THE ENDOLEAK RESOLVED AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN ASSESSED RELATIONSHIP TO THE DEVICE IS UNKNOWN AND NOT RELATED TO THE PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
289442	TALENT	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	MEDTRONIC IRELAND

Patients

Seq	Age	Sex	Outcome	Treatment
1	00062 YR		Required Intervention