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

Catalog Number	8581W
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Blood Loss (2597); No Code Available (3191)
Date of Event	10/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.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.Additional information was requested and the following was obtained: please ask if the surgeon is interested in speaking directly with engineering and medical safety team regarding the event? patient: the patient demographic info: weight, bmi at the time of index procedure - no information.The diagnosis and indication for the index surgical procedure? aaa.Patient pre-existing medical conditions / patient history/ medications -no information.Please provide the official cause of death -no information.If an autopsy has been performed or planned, may we have a copy of the autopsy report when its available? the autopsy was performed, however details were not provided.We were provided only information regarding suture breakage.May we have a copy of the operative report ? we couldnt get it.Procedure: initial procedure date - (b)(6) 2016.Was the surgery urgent or elective? no information.Were there any concomitant procedures performed? no information.Were 2 sizes of suture used on this patient (4-0 and 6-0 prolene)? the possible lot number, jdj600, is misinformation.It was used only 4-0 prolene.What tissue location of the placement of 8581 (4-0 prolene) suture? it was used to rebuild the aorta with a synthetic graft.What tissue location of the placement of 8806 (6-0 prolene) suture? the 6-0 prolene was not used in the procedure.The lot number which was provided from the hospital was wrong number.This hospital doesnt purchase 8806.Were both suture sizes placed continuous? it was used only 4-0 prolene.It was definite that the 4-0 prolene was placed continuous in initial procedure.But it is unknown whether the additional suturing was placed continuous or interrupted.How the suture was initially tied ( square knot or multiple knots one end)? no information.Was the anastomosis completed successfully? no information.Was any anomaly noted with 4-0 prolene or 6-0 prolene suture prior to use? no information.Which great vessel was the suture used? probably abdominal aorta, because the diagnosis was aaa.How was the vessel wall tissue condition, normal, fragile, or calcified, etc? no information.Where was the patient sent for recovery immediately after the surgery? no information.Was there any post op triggering event or precipitating stress factors ? no information.Please describe suture condition post op? in re-operation, the surgeon checked the suture was not broken what was the location of the bleeding site (which suture was used)? the anastomosis site (the suture was used).Was any suture breakage observed? in re-operation, the surgeon checked the suture was not broken.Or did tissue pulled away from the suture line? no information.What was used to fix and reinforce the bleeding site? additional suturing using 4-0 prolene.According to the operating surgeon, what were the cause and contributing factors for the patient death? no information.Any additional information product: will the actual product used in the surgery be returned for analysis? no.Will any un-opened sutures from the same lot be returned for evaluation? no.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement and during any re-operation/autopsy? in re-operation, the surgeon checked the suture was not broken.However, the suture breakage was observed in the anomaly.It was not clear that the broken suture was used in the initial surgery or in the re-operation.This is the highly sensitive issue for the hospital, so we cannot get the information any more.
Event or Problem Description
It was reported that the patient underwent great vessel /abdominal aortic aneurysm repair procedure on (b)(6) 2016 and the suture was placed continuous to rebuild the abdominal aorta with a synthetic graft.On the following day, the patient experienced bleeding from the suturing site and underwent a reoperation on (b)(6) 2016.During the reoperation, the surgeon checked the suture was not broken and additional suturing was done in order to fix and reinforce the bleeding site.

• Brand Name: PROLENE POLYPROPYLENE SUTURE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 6096034
• Report Number: 2210968-2016-14874
• Device Sequence Number: 391082
• Product Code: GAW
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/21/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 8581W
• Device Lot Number: KGJ901
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2016
• Initial Report FDA Received Date: 11/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SYNTHETIC GRAFT
• Outcome Attributed to Adverse Event: Required Intervention