GORE® TAG® THORACIC ENDOPROSTHESIS

MDR report key: 4191639 · Received October 22, 2014

Report

Report Number: 2017233-2014-00544
Event Type: Malfunction
Date Received: October 22, 2014
Date of Event: September 22, 2014
Report Date: November 5, 2014
Manufacturer: W.L. GORE & ASSOCIATES
Product Code: MIH
PMA / PMN Number: P040043
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

THE REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ONLY PICTURES WERE RECEIVED BY GORE FOR EVALUATION AS THE SPECIMEN IS NOT AVAILABLE FOR RETURN.

Description of Event or Problem · 1

ON (B)(6) 2014, THE PATIENT WAS TO BE IMPLANTED WITH A GORE® TAG® THORACIC ENDOPROSTHESIS (ITEM#: TAG3720, LOT#:9982886) FOR TREATMENT OF A LARGE THORACIC AORTIC DISSECTION INVOLVING THE ASCENDING AORTA, THE AORTIC ARCH AND THE DESCENDING AORTA. IT WAS REPORTED THE PHYSICIAN ENCOUNTERED DIFFICULTY WHEN ADVANCING THE DEVICE IN THE AORTIC ARCH. X-RAY FLUOROSCOPY REVEALED THE DEVICE HAD PARTIALLY DEPLOYED AT THE DISTAL END. THE PHYSICIAN WAS ABLE TO WITHDRAW THE DEVICE WITHOUT INJURY TO THE PATIENT. FURTHER INSPECTION OF THE DEVICE REPORTEDLY CONFIRMED DISTAL DISPLACEMENT ON THE CATHETER, AS WELL AS PARTIAL DEPLOYMENT ON THE PROXIMAL END. THE PHYSICIAN USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
673511	GORE® TAG® THORACIC ENDOPROSTHESIS	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	W.L. GORE & ASSOCIATES		9982886

Patients

Seq	Age	Sex	Outcome	Treatment
1	46 YR		Other