FDA Adverse Event Death Summary report: N

ENDO STITCH

MDR report key: 8432902 · Received March 19, 2019

Report

Report Number: 9612501-2019-00549
Event Type: Death
Date Received: March 19, 2019
Date of Event: April 23, 2014
Report Date: March 19, 2019
Manufacturer: DAVIS & GECK CARIBE LTD
Product Code: OCW
UDI-DI: 10884521100008
PMA / PMN Number: K934738
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NL
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

TITLE MINIMALLY INVASIVE OESOPHAGECTOMY: PRELIMINARY RESULTS AFTER INTRODUCTION OF AN INTRATHORACIC ANASTOMOSIS SOURCE DIGESTIVE SURGICAL, 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 FROM JANUARY 2011 UNTIL AUGUST 2012, 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 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
226421	ENDO STITCH	ENDOSCOPIC TISSUE APPROXIMATION DEVICE	OCW	DAVIS & GECK CARIBE LTD	173016		10884521100008

Patients

Seq	Age	Sex	Outcome	Treatment
1	66 YR		Death