UNKNOWN VLOC ENDO STITCH RELOAD ABS

Report

Report Number: 1219930-2019-01536
Event Type: Death
Date Received: March 14, 2019
Date of Event: April 23, 2014
Report Date: March 14, 2019
Manufacturer: COVIDIEN LP LLC NORTH HAVEN
Product Code: GAM
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NL
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). (SURGICAL INTERVENTION REQUIRED) TITLE MINIMALLY INVASIVE OESOPHAGECTOMY: PRELIMINARY RESULTS AFTER INTRODUCTION OF AN INTRATHORACIC ANASTOMOSIS SOURCE DIGESTIVE SURGICAL, VOLUME 31, 2014 (95-103) DATE OF PUBLICATION: 23 APRIL 2014. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED, A TOTAL OF 45 OPERABLE PATIENTS WERE SCHEDULED TO UNDERGO MINIMALLY INVASIVE ESOPHAGECTOMY (MIE) WITH INTRATHORACIC ANASTOMOSIS. EIGHTEEN OUT OF THE 45 PATIENTS WERE UNDER GROUP 2 WHEREIN A CIRCULAR STAPLER WAS USED TO CREATE AN INTRATHORACIC ANASTOMOSIS ALONG WITH ITS ANVIL BEING INSERTED THROUGH ONE OF THE PORTS AND SECURED WITH 2 PURSE STRINGS USING THE STITCHING DEVICE AND SUTURE. ONE OF THE PATIENT'S POST-OPERATIVE COURSE COMPLICATED BY CHYLE LEAKAGE, AND THIS WAS MANAGED CONSERVATIVELY WITH TOTAL PARENTERAL FEEDING DURING 6 DAYS. A CONTRAST SWALLOW COMPUTED TOMOGRAPHY (CT) SCAN 4 DAYS POST-OPERATIVELY SHOWED NO SIGNS OF ANASTOMOTIC LEAKAGE. THE PATIENT DIED 25 DAYS AFTER SURGERY OF MASSIVE HEMORRHAGE FROM A GASTRO-AORTIC FISTULA AT THE LEVEL OF THE ANASTOMOSIS REQUIRING EMERGENCY SURGERY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
215023	UNKNOWN VLOC ENDO STITCH RELOAD ABS	SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID	GAM	COVIDIEN LP LLC NORTH HAVEN	UNKNOWN VLOC ENDO STITCH RELOAD ABS

Patients

Seq	Age	Sex	Outcome	Treatment
1	66 YR		Death