FDA Adverse Event Injury Summary report: N

GORE® EXCLUDER® AAA ENDOPROSTHESIS

MDR report key: 3884043 · Received June 19, 2014

Report

Report Number: 3007284313-2014-00049
Event Type: Injury
Date Received: June 19, 2014
Date of Event: April 5, 2014
Report Date: May 21, 2014
Manufacturer: W.L. GORE & ASSOCIATES
Product Code: MIH
PMA / PMN Number: P020004
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THESE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. ADDITIONAL DEVICES IMPLANTED AND/OR RELATED TO THIS EVENT: PLA360400/12023131 AND PLA360400/12023132. THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU) STATES THAT ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO RENAL (E.G., CONTRAST TOXICITY, INSUFFICIENCY, FAILURE).

Description of Event or Problem · 1

ON (B)(6) 2014, THE PATIENT WAS IMPLANTED WITH FOUR GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT SUFFERED ACUTE KIDNEY INJURY DUE TO THE CONTRAST THAT WAS ADMINISTERED TO THE PATIENT DURING THE PROCEDURE AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. ON (B)(6) 2014, THE PATIENT WAS READMITTED TO THE HOSPITAL AND WAS DIAGNOSED WITH A CONTRAST INDUCED KIDNEY INJURY WITH UNDERLYING RENAL DISEASE, RESPIRATORY FAILURE, AND SEPSIS. THE PATIENT WAS TREATED WITH DIURESIS FOR THE RENAL REPLACEMENT AND THE SEPSIS AND RESPIRATORY ISSUE WERE ALSO RESOLVED, THE PATIENT WAS DISCHARGED ON (B)(6) 2014.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
360432	GORE® EXCLUDER® AAA ENDOPROSTHESIS	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	W.L. GORE & ASSOCIATES		11780873

Patients

Seq	Age	Sex	Outcome	Treatment
1	91 YR		Other