FDA Adverse Event Injury Summary report: N

GORE TAG THORACIC ENDOPROSTHESIS

MDR report key: 3082947 · Received April 23, 2013

Report

Report Number: 2017233-2013-00249
Event Type: Injury
Date Received: April 23, 2013
Date of Event: March 28, 2013
Report Date: March 28, 2013
Manufacturer: W.L. GORE & ASSOCAITES
Product Code: MIH
PMA / PMN Number: P040043
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. PER THE GORE TAG THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE TAG THORACIC ENDOPROSTHESIS MAY INCLUDE BUT ARE NOT LIMITED TO ENDOLEAK AND ANEURYSM ENLARGEMENT.

Description of Event or Problem · 1

ON (B)(6) 2012, THE PT WAS IMPLANTED WITH A CONFORMABLE GORE TAG THORACIC ENDOPROSTHESIS TO TREAT A DISSECTION WITH FALSE LUMEN ANEURYSM. ON (B)(6) 2013, COMPUTED TOMOGRAPHY (CT) SCAN REVEALED WHAT WAS INITIALLY SUSPECTED TO BE A PROXIMAL TYPE I ENDOLEAK. THE SUSPECTED LEAK REPORTEDLY CONTRIBUTED TO FALSE LUMEN ANEURYSM ENLARGEMENT (AMOUNT UNK). IT WAS REPORTED THAT THE LEFT SUBCLAVIAN ARTERY (LSA) WAS LIGATED, AND THEN INTENTIONALLY COVERED DURING THE INITIAL PROCEDURE. THE PHYSICIAN INDICATED THAT THE LSA MAY NOT HAVE BEEN COMPLETELY COVERED, WHICH MAY HAVE CAUSED THE LEAK. THE PT WILL HAVE A CT SCAN OF THE NECK. IF THE LSA IS SHOWN TO HAVE FLOW, THEN RE-INTERVENTION WILL BE SCHEDULED TO PLUG OR COIL THE LSA, THEN PROXIMALLY EXTEND THE STENT-GRAFT SYSTEM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
174518	GORE TAG THORACIC ENDOPROSTHESIS	MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	W.L. GORE & ASSOCAITES		9834423

Patients

Seq	Age	Sex	Outcome	Treatment
1	66 YR		Other