GORE® TAG® THORACIC ENDOPROSTHESIS

MDR report key: 4263456 · Received November 19, 2014

Report

Report Number: 2017233-2014-00610
Event Type: Injury
Date Received: November 19, 2014
Date of Event: June 28, 2010
Report Date: October 23, 2014
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 THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

Description of Event or Problem · 1

ON (B)(6) 2010, PRIOR TO ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM, THE VASCULAR BYPASS PROCEDURE WAS PERFORMED BETWEEN THE RIGHT COMMON CAROTID ARTERY AND THE LEFT COMMON CAROTID ARTERY. ON (B)(6) 2010, THE PATIENT WAS IMPLANTED WITH TWO GORE® TAG® THORACIC ENDOPROSTHESES (TGT3420/7858625, TGT3720/7893440). ANY ENDOLEAK WAS NOT REVEALED, BUT THE PATIENT DEVELOPED CEREBRAL INFARCTION. ON THE SAME DAY, MEDICATIONS WERE ADMINISTERED TO TREAT THE CEREBRAL INFARCTION. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED OF THE HOSPITAL WITH THE CEREBRAL INFARCTION STILL REMAINING. FOLLOW-UP STUDIES WERE DISCONTINUED AS THE PATIENT WAS ADMITTED TO ANOTHER HOSPITAL. THE PATIENT CONDITION INCLUDING THE CEREBRAL INFARCTION WAS REPORTEDLY UNKNOWN. IT WAS REPORTED THAT THROMBUS OR PLAQUE MAY HAVE BEEN SPREAD DURING THE DEVICE MANIPULATION AND OCCLUDED SOME CEREBRAL VESSELS. IT COULD BE A POSSIBLE CAUSE OF THE CEREBRAL INFARCTION. THE PATIENT RECEIVED A REHABILITATION THERAPY AFTER MEDICATIONS HAD BEEN GIVEN TO TREAT THE CEREBRAL INFARCTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
749605	GORE® TAG® THORACIC ENDOPROSTHESIS	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	W.L. GORE & ASSOCIATES		7858625

Patients

Seq	Age	Sex	Outcome	Treatment
1	74 YR		Hospitalization\| R\| S	(B)(4)