FDA Adverse Event Injury Summary report: N

VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT

MDR report key: 7174737 · Received January 9, 2018

Report

Report Number: 2210968-2018-70127
Event Type: Injury
Date Received: January 9, 2018
Report Date: December 11, 2017
Manufacturer: ETHICON INC.
Product Code: FTL
PMA / PMN Number: K810428
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED VIA JOURNAL ARTICLE, ¿USE OF ABSORBABLE MESH IN THE TREATMENT OF PARENCHYMAL LIVER INJURIES DURING ORTHOTOPIC LIVER TRANSPLANTATION¿ THAT A STUDY WAS COMPLETED TO EVALUATE THE USE OF ABSORBABLE MESH TO CONTROL HAEMORRHAGE IN THE TREATMENT OF PARENCHYMAL LIVER INJURIES IN ORTHOTOPIC LIVER TRANSPLANTATIONS (OLT). THE AUTHORS STUDIED THE CASE NOTES OF 609 PATIENTS WHO HAD OLT BETWEEN JANUARY 1988 AND JULY 1998. OF THE 609 OLTS PERFORMED, PARENCHYMAL LIVER INJURY WAS DIAGNOSED IN 27 CASES. FIFTEEN (15) OF THESE LESIONS WERE TREATED WITH MESH WRAPPING (N=9; 6 MALES, 3 FEMALES; MEAN AGE 51 YEARS [RANGE 41-65]) OR MESH PACKING (N=6; 3 MALES, 3 FEMALES; MEAN AGE 51 YEARS [RANGE 40-60]). ONE PATIENT REQUIRED RELAPAROTOMY BECAUSE OF HEPATIC ARTERY THROMBOSIS AFTER MESH PACKING. THIS PATIENT HAD A SUCCESSFUL THROMBECTOMY WITHIN 48 HOURS OF TRANSPLANTATION AND THE AUTHORS CANNOT EXCLUDE THE POSSIBILITY THAT THE PACKING CAUSED THE THROMBOSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
20912	VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT	MESH, SURGICAL, POLYMERIC	FTL	ETHICON INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	51 YR		Required Intervention