TALENT THORACIC STENT GRAFT SYSTEM

MDR report key: 1833625 · Received September 8, 2010

Report

Report Number: 2953200-2010-01715
Event Type: Injury
Date Received: September 8, 2010
Date of Event: August 10, 2010
Report Date: August 10, 2010
Manufacturer: MEDTRONIC CARDIOVASCULAR GALWAY
Product Code: MIH
PMA / PMN Number: P070007
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4): EVALUATION RESULTS: PARALYSIS.

Description of Event or Problem · 1

A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF THREE THORACIC AORTIC ANEURYSMS. THE PATIENT HAD A BOVINE AORTIC ARCH AND A PREVIOUSLY-PLACED INFRARENAL ABDOMINAL AORTIC ANEURYSM STENT GRAFT FROM ANOTHER MANUFACTURER. THE NATIVE THORACIC AORTA IS ABOUT 36 MM IN DIAMETER. ACCESS VESSELS HAD MILD CALCIFICATION. IT WAS REPORTED THAT A TALENT CAPTIVIA STENT GRAFT (MFR REPORT # 2953200-2010-01714) WAS DELIVERED EASILY TO THE TARGET ZONE AND IMPLANTED PROXIMALLY. THEN, TWO TALENT THORACIC DISTAL MAIN STENT GRAFTS (MFR REPORT # 2953200-2010-01716) WERE DEPLOYED, ALTHOUGH THERE WAS SOME DIFFICULTY REACHING THE ANEURYSMS. THE CASE WENT VERY WELL WITH GOOD PLACEMENT OF THE STENT GRAFTS. APPROXIMATELY 30 MINUTES POST-IMPLANTATION, WHEN THE PHYSICIAN WAS CLOSING THE GROIN, A CHECK OF THE PATIENT'S STATUS REVEALED THAT THERE WAS PARAPLEGIA IN THE RIGHT LEG, ALTHOUGH THE LEFT LEG WAS FINE. A SPINAL DRAIN WAS THEN PLACED TO INTERVENE, AND THE PARALYSIS WAS RESOLVED; THE PATIENT HAS REGAINED RIGHT LEG MOBILITY. 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		MIH	MEDTRONIC CARDIOVASCULAR GALWAY	NA	V00480646

Patients

Seq	Age	Sex	Outcome	Treatment
1	82 YR		Required Intervention