TALENT THORACIC STENT GRAFT SYSTEM

MDR report key: 1983057 · Received February 4, 2011

Report

Report Number: 2953200-2011-00284
Event Type: Injury
Date Received: February 4, 2011
Date of Event: October 1, 2010
Report Date: January 7, 2011
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

Narratives

Additional Manufacturer Narrative · 1

(B)(4). EVAL, RESULTS: CVA/STROKE, DISSECTION. EVAL, RESULTS/CONCLUSION: STENOSIS IN THE VESSELS.

Description of Event or Problem · 1

A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A PENETRATING ATHEROSCLEROTIC ULCER 59 MM IN DIAMETER X 135 MM LONG AT ZONE 3 FOUR MONTHS AGO. THE PROXIMAL NECK DIAMETER WAS 34MM; DISTAL NECK WAS 38MM IN DIAMETER. THE LENGTHS FROM THE UPPER AND LOWER ARCH TO THE PROXIMAL NECK WERE BOTH 27MM. THERE WAS NO CALCIFICATION, BUT MILD THROMBUS AT THE PROXIMAL AND DISTAL NECKS. A TALENT TF3838 (REF MFR # 2953200-2011-00283) WAS IMPLANTED IN THE DISTAL SIDE OF THE PAU, FOLLOWED BY A TF4242 IMPLANTED IN THE PROXIMAL SIDE OF THE PAU WITH SUCCESSFUL RESULTS. ON AN UNK DATE, A CEREBRAL INFARCTION OCCURRED AND AT THE TIME OF DISCHARGE, A VESSEL DISSECTION WAS CONFIRMED. STENOSIS WAS CONFIRMED AT THE ROOT OF THE LEFT SUBCLAVIAN, AND THE PT UNDERWENT TREATMENT WITH MEDICATION AND REHABILITATION. THE PT IS IN REMISSION. THE PHYSICIAN COMMENTED THAT THERE IS A POSSIBILITY THAT THE STENOSED PART OF THE VESSEL DISSECTED AND CAUSED THE CEREBRAL INFARCTION. NO ADD'L CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS IN REMISSION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TALENT THORACIC STENT GRAFT SYSTEM		MIH	MEDTRONIC CARDIOVASCULAR	NA	V00314612

Patients

Seq	Age	Sex	Outcome	Treatment
1	72 YR		Required Intervention