TALENT THORACIC STENT GRAFT SYSTEM

MDR report key: 1931922 · Received November 30, 2010

Report

Report Number: 2953200-2010-02349
Event Type: Malfunction
Date Received: November 30, 2010
Date of Event: November 1, 2010
Report Date: November 1, 2010
Manufacturer: MEDTRONIC CARDIOVASCULAR GALWAY
Product Code: MIH
PMA / PMN Number: P070007
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 1

(B)(4). (RESULTS,CONCLUSIONS): HIGHLY ANGULATED ANATOMY, USE OF DEVICE IN ZONE 1.

Description of Event or Problem · 1

A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 4.2 CM THORACIC AORTIC ANEURYSM IN ZONE 1 APPROXIMATELY ONE MONTH AGO. VESSEL MORPHOLOGY WAS REPORTED AS HIGHLY ANGULATED ANATOMY. THE TEVAR INVOLVED COVERAGE OF THE LCCA, WHICH WAS TO BE PERFUSED VIA A CHIMNEY-UP TECHNIQUE. THE TW4440 WAS IMPLANTED INTO THE DISTAL SIDE OF THE TAA SUCCESSFULLY WITHOUT ANY ISSUES. THE TALENT THORACIC DEVICE SIZE TF4646 DELIVERY SYSTEM WAS THEN ADVANCED PROXIMALLY. WHEN THE PHYSICIAN STARTED TO EXPAND THE BARE SPRING, THE BARE SPRING WAS INVERTED TOWARD THE INTERNAL SIDE. THEN, THE PHYSICIAN ATTEMPTED TO PULL BACK THE DELIVERY SYSTEM FOR RECOVERY OF THE INVERTED SPRING, BUT COULD NOT. THE PHYSICIAN WILL MONITOR THE INVERTED BARE SPRING WITHOUT ANY ADDITIONAL TREATMENT AT THE TIME OF THE PROCEDURE. NO 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	V00541199

Patients

Seq	Age	Sex	Outcome	Treatment
1	81 YR	Male