FDA Adverse Event Injury Summary report: N

GORE® TAG® THORACIC ENDOPROSTHESIS

MDR report key: 5340683 · Received January 4, 2016

Report

Report Number: 2017233-2016-00009
Event Type: Injury
Date Received: January 4, 2016
Date of Event: June 17, 2011
Report Date: December 21, 2015
Manufacturer: W.L. GORE & ASSOCIATES
Product Code: MIH
PMA / PMN Number: P040043
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. THE ROOT CAUSE OF THE ANEURYSM ENLARGEMENT COULD NOT BE DETERMINED WITH THE PROVIDED INFORMATION. ADDITIONAL DEVICES IMPLANTED AND INVOLVED IN THIS EVENT: TGT4020/8440593 AND TGT3720/7850882 (B)(4).

Description of Event or Problem · 1

ON (B)(6) 2010, THE PATIENT UNDERWENT A PROCEDURE USING THREE GORE TAG THORACIC ENDOPROSTHESES TO TREAT A THORACOABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED ON DISCHARGE DATE OF (B)(6) 2010, THE ANEURYSM DIAMETER MEASURED 62.0 MM. ON (B)(6) 2011, FOLLOW-UP IMAGINING IDENTIFIED AN ANEURYSM DIAMETER MEASUREMENT OF 67.0 MM. ON (B)(6) 2011, FOLLOW-UP IMAGINING IDENTIFIED AN ANEURYSM DIAMETER MEASUREMENT OF 66.0 MM. ON (B)(6) 2012, FOLLOW-UP IMAGINING IDENTIFIED AN ANEURYSM DIAMETER MEASUREMENT OF 69.0 MM. ON (B)(6) 2013, FOLLOW-UP IMAGINING IDENTIFIED AN ANEURYSM DIAMETER MEASUREMENT OF 62.0 MM. THE CAUSE OF THE ANEURYSM ENLARGEMENT IS UNKNOWN. REPORTEDLY, AN INTERVENTION TO TREAT THE ANEURYSM ENLARGEMENT HAS NOT BEEN PERFORMED. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION ON THIS EVENT, HOWEVER NO ADDITIONAL INFORMATION WILL BE PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1139	GORE® TAG® THORACIC ENDOPROSTHESIS	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	W.L. GORE & ASSOCIATES		8173817

Patients

Seq	Age	Sex	Outcome	Treatment
1	79 YR		Hospitalization\| O