GORE TEX® VASCULAR GRAFT

MDR report key: 3831628 · Received May 26, 2014

Report

Report Number: 2017233-2014-00271
Event Type: Death
Date Received: May 26, 2014
Date of Event: January 1, 2014
Report Date: April 28, 2014
Manufacturer: W.L. GORE & ASSOCIATES
Product Code: DSY
PMA / PMN Number: K802095
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

NO FURTHER INFORMATION IS AVAILABLE.

Description of Event or Problem · 1

IN REVIEW OF PUBLISHED LITERATURE, THESE FINDINGS WERE NOTED: MIN BAO, PH.D., HONGYIN LI, M.D., GUANGYU PAN, M.D., ZHONGHUA XU, M.D. AND QINGYU WU, M.D., "CENTRAL SHUNT PROCEDURES FOR COMPLEX CONGENITAL HEART DISEASES", J CARD SURG 2014;XX:1-5 PUBLISHED ONLINE 2014, DOI: 10.1111/JOCS.12343. BETWEEN APRIL 2004 AND NOVEMBER 2012, TOTAL 110 PATIENTS (MEDIAN AGE,11MONTHS;MEDIAN WEIGHT, 9KG) WITH THE COMPLEX CONGENITAL HEART DISEASES WERE TREATED WITH THE GORE-TEX GRAFTS IN THE SHUNT OPERATION, THE GRAFT SIZE WAS DETERMINED PRIMARILY BASED ON THE PATIENTS' BODY WEIGHT PRIOR TO THE OPERATIONS. THE ARTICLE DESCRIBES ONE PATIENT WITH PULMONARY ARTERY ATRESIA, VENTRICULAR SEPTAL DEFECT, AND SEVERELY HYPOPLASTIC NATIVE PULMONARY ARTERIES (DIAMETER 2MM) WITHOUT PATENT DUCTUS ARTERIOSUS OR MAJOR AORTA-PULMONARY COLLATERAL ARTERIES EXPERIENCED CONTINUOUS LOW O2 SATURATION AND SUFFERED AN ACUTE SHUNT OCCLUSION AT DAY 15 POST OPERATION AND DIED AFTER A SECOND SHUNT OPERATION. THE AUTHOR DOES NOT INDICATE A REASON FOR THE DEATH.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
309950	GORE TEX® VASCULAR GRAFT	PROSTHESIS, VASCULAR GRAFT	DSY	W.L. GORE & ASSOCIATES

Patients

Seq	Age	Sex	Outcome	Treatment
1			Death