TALENT THORACIC STENT GRAFT SYSTEM WITH XCELERANT

MDR report key: 1953511 · Received January 5, 2011

Report

Report Number: 2953200-2011-00005
Event Type: Injury
Date Received: January 5, 2011
Date of Event: December 3, 2010
Report Date: March 2, 2014
Manufacturer: MEDTRONIC CARDIOVASCULAR
Product Code: MIH
PMA / PMN Number: P070007
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN
Health Professional: N

Narratives

Additional Manufacturer Narrative · 1

(B)(4): EVALUATION, RESULTS: (ENDOLEAK). EVALUATION, CONCLUSIONS: (LACK OF INFORMATION).

Description of Event or Problem · 1

A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT 3 DAYS POST INITIAL IMPLANT THAT A SLIGHT ENDOLEAK WAS CONFIRMED BY ANGIOGRAPHY AND TEE (TRANSESOPHAGEAL ECHOCARDIOGRAPHY). THE FOLLOWING DAY THE LSA WAS OCCLUDED BY COIL AND THE TYPE I ENDOLEAK RESOLVED WITH A TALENT EXTENSION DEVICE THAT WAS IMPLANTED IN THE PROXIMAL END. THE ENDOLEAK DISAPPEARED AFTER BALLOONING JUST UNDER THE MINI SUPPORT SPRING. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TALENT THORACIC STENT GRAFT SYSTEM WITH XCELERANT		MIH	MEDTRONIC CARDIOVASCULAR	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	00080 YR	Male	Required Intervention