MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2019-04-05 for SUTURE UNKNOWN manufactured by Ethicon Inc..
[141105055]
(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. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. Were the cases discussed in this article previously reported to ethicon? If yes, please provide a complaint reference number. Does the surgeon believe that ethicon products (pds ii, prolene, vicryl plus, unknown absorbable suture) involved caused and/or contributed to the post-operative complications described in the article? Does the surgeon believe there was any deficiency with the ethicon products (pds ii, prolene, vicryl plus, unknown absorbable suture) used in this procedure? Please confirm with the authors what are the specific? Other? Complications noted in table 3 of the article, and if the ethicon device caused/contributed to the reported events. The american surgeon (2018); 84: 371-376. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[141105056]
It was reported via journal article: title: "addition of mesh reinforcement for pancreatic stump and braun enteroenterostomy after pancreaticoduodenectomy: a single institution experience," author(s): jie hua, m. D. , hongbo meng, m. D. , zhigang he, m. D. , le yao, m. D. , wei sun, m. D. , ph. D. , zhenshun song, m. D. , ph. D. , citation: the american surgeon (2018); 84: 371-376. This study investigated a new modification of pd by adding mesh reinforcement for the pancreatic stump and braun enteroenterostomy with the aim of reducing postoperative pancreatic fistula (popf) and delayed gastric emptying (dge), respectively. From november 2010 to april 2015, 81 consecutive patients (male 51 and female 30; age range: 24-80; bmi: 18. 1-29. 6) who underwent modified pd were retrospectively reviewed. After the pd specimen had been removed, hemostasis of the bleeding points of the pancreatic stump was achieved with either 4-0 prolene nonabsorbable sutures (ethicon) or electrocautery. Two sutures were typically placed in both the superior and inferior borders of the pancreatic stump for dragging. The catheter was secured to the pancreatic duct using 4-0 vicryl plus absorbable sutures (ethicon), preventing catheter migration. A mesh-like running suture of the pancreatic stump using 4-0 prolene nonabsorbable sutures (ethicon) was performed, aiming to reduce the wound of the pancreatic stump. Briefly, running sutures were performed from the inferior border to the superior border. To maximally seal the pancreatic stump, running sutures from the superior border back to the inferior border were performed to form mesh-like intersections with the previous sutures. The transected jejunum was then brought through the bed of the resected duodenum and a two-layer end-to-end invagination pj using 4-0 prolene nonabsorbable sutures (ethicon) was performed. The hepaticojejunostomy was performed downstream from the pj (approximately 10 cm) using 4-0 polydioxanone (pds) ii absorbable sutures (ethicon) in a single-layer continuous nonlocking fashion. The gastrojejunostomy was performed 60 cm distal to the pj with an outer interrupted layer of 3-0 silk and an inner continuous layer of 3-0 absorbable suture (ethicon). Reported complications included postoperative pancreatic fistula (n-8), delayed gastric emptying (n-26), postpancreatectomy hemorrhage (n-6), bile leak (n-3), intra-abdominal collection (n-13), wound infection (n-8), abdominal wound dehiscence (n-1) in which reoperation was performed, other (n-9), and one patient experienced grade c popf and soon developed sepsis leading to death. In conclusion, the new modified digestive reconstruction after pd seems safe and reliable with low clinically relevant popf and dge rates. Further prospective controlled trials are essential to support these results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-80073 |
| MDR Report Key | 8488808 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2019-04-05 |
| Date of Report | 2019-03-12 |
| Date Mfgr Received | 2019-03-12 |
| Date Added to Maude | 2019-04-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DARLENE KYLE |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082182792 |
| Manufacturer G1 | ETHICON INC. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUTURE UNKNOWN |
| Generic Name | SUTURE, NONABSORBABLE |
| Product Code | GAO |
| Date Received | 2019-04-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-05 |