TALENT THORACIC STENT GRAFT (CT)

MDR report key: 1910649 · Received November 22, 2010

Report

Report Number: 2953200-2010-02292
Event Type: Injury
Date Received: November 22, 2010
Date of Event: September 14, 2010
Report Date: October 24, 2010
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). EVALUATION: RESULTS: (ENDOLEAK); (MODERATELY CALCIFIED VESSELS). CONCLUSIONS: (MODERATELY CALCIFIED VESSELS).

Description of Event or Problem · 1

A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A SACCULAR IN ZONE 4 MEASURING 70MM THORACIC AORTIC ANEURYSM TWO MONTHS AGO. THE PROXIMAL THORACIC NECK DIAMETER IS 30MM, DISTAL DIAMETER NECK IS 27MM AND IT IS MODERATELY CALCIFIED. THE ILIAC ARTERIES WERE MODERATELY CALCIFIED. IT WAS REPORTED THAT A TALENT STENT GRAFT (B)(4) IMPLANTED PROXIMALLY AND THE SECOND DEVICE WAS A (B)(4) IMPLANTED DISTALLY. THERE WERE NO ENDOLEAKS UPON FINAL ANGIOGRAM. IT WAS REPORTED 6 DAYS POST STENT GRAFT IMPLANT THE CT DEMONSTRATED THAT THERE WAS A DISTAL TYPE 1B ENDOLEAK PRESENT AND THE ANEURYSM WAS 73MM IN DIAMETER. THE PHYSICIAN PERFORMED A COIL EMBOLIZATION (TO THE PART OF TYPE 1B ENDOLEAK, A GAP OF THE DISTAL LANDING ZONE BETWEEN THE NATIVE AORTIC WALL AND TALENT) AND THE ENDOLEAK WAS RESOLVED. AFTER THE INTERVENTION THE TYPE 1B ENDOLEAK RE-APPEARED. SIXTEEN DAYS LATER ANOTHER INTERVENTION WAS PERFORMED AND COIL EMBOLIZATION AND THE ENDOLEAK WAS RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TALENT THORACIC STENT GRAFT (CT)		MIH	MEDTRONIC CARDIOVASCULAR	NA	V00323726

Patients

Seq	Age	Sex	Outcome	Treatment
1	75 YR		Required Intervention