MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE

Device Problem Insufficient Information (3190)

Patient Problems Syncope (1610); Pseudoaneurysm (2605); Foreign Body In Patient (2687); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4) this report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.Citation: obes surg.2008; 18: 890¿892.Doi: 10.1007/s11695-007-9411-9.(b)(4).

Event Description

It was reported via journal article title: delayed rupture of a splenic artery pseudoaneurysm after biliopancreatic diversion authors: prashant k.Upadhyaya, soujanya chava, syed bin-sangheer, ranjan sudan, sumeet k.Mittal, samuel cemaj.Citation: obes surg.2008; 18: 890¿892.Doi: 10.1007/s11695-007-9411-9.This case report involved a (b)(6) man was admitted from the emergency room after presenting with massive hemetemesis and syncope.His past history was significant for an open bpd-ds 2 years ago.An emergency gastroesophagoscopy was done.However, the source of bleeding could not be identified owing to large amount of clots in the stomach and jejunum.A decision to perform an en bloc splenectomy along with removal of the portion of adherent stomach was made.The bleeding totally ceased on dissecting and clamping the proximal splenic artery at the level of pancreas.On visual examination of the specimen upon opening up of the stomach, we identified a prolene stitch used in the reinforcement of sleeve gastrectomy to be abutted against a splenic artery pseudoaneurysm (sap) and entering into the stomach.This pseudoaneurysm, 3 cm in diameter, was opening into the stomach through the sleeve gastrectomy anastomosis.Treatment included leaving the proximal and distal halves of the stomach unconnected and placed a wound vacuum-assisted closure on the open abdomen as part of damage control surgery.Two days later, the patient was taken up for surgery and the stomach continuity restored by end-to-end anastomosis after extensive adhesiolysis.The patient had a prolonged recovery due owing to his co-morbidities but managed to be discharged in a healthy condition.It was reported that the case was unique in that the cause of sap was iatrogenic.The adventitia of the distal splenic artery was probably damaged by the prolene stitch taken during placement of the reinforcing layer to the gastric sleeve anastomosis.Alternatively, the prolene suture could gradually have eroded into the splenic arterial wall to form the sap.It was concluded that the possibility of sap should be kept in mind in cases of gi bleeds in patients having undergone surgery in the peripancreatic area, especially with an inconclusive upper gi endoscopy.

• Brand Name: PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7631746
• MDR Text Key: 112155836
• Report Number: 2210968-2018-73714
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2018
• Initial Date FDA Received: 06/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR