MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2020-03-30 for ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN manufactured by Ethicon Inc..
[186518692]
(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. Does the surgeon believe that ethicon products (ethibond suture) involved caused and/or contributed to the post-operative complications of severe systemic infection, infection, uncontrollable bleeding and patient deaths described in the article? Does the surgeon believe there was any deficiency with the ethicon products (ethibond suture) used in this procedure? Patient demographics. Lot number and product code of ethibond suture. Were the cases discussed in this article previously reported to ethicon? If yes, please provide a complaint reference number(s). Citation: asian cardiovascular & thoracic annals 2019, vol. 27(7) 535? 541. Doi: 10. 1177/0218492319869560. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[186518693]
It was reported via journal article: "title: incidence and predictors of mismatch after mechanical mitral valve replacement" authors: ashraf ah el midany1 , ezzeldin a mostafa1 , tamer hikal1, mostafa g elbarbary1, ayman doghish1, ramy khorshid1 , basem m abdelgawad2 , mohamed sharaa3, ismail n el-sokkary3, mohamed el hossiny3, haytham abdelmoaty3 and bahaa a elkhonezy citation: asian cardiovascular & thoracic annals 2019, vol. 27(7) 535? 541. Doi: 10. 1177/0218492319869560. The purpose of this study was to determine the incidence of patient-prosthesis mismatch (ppm) after mitral valve replacement (mvr), and to identify predictors of this phenomenon so that preventive strategies can be planned before surgery. This prospective study involves 715 patients (305 male and 410 female; mean age: 42? 11 years; mean body surface area: 1. 83? 0. 2m2) who underwent mechanical mvr between 2013 and 2017. The brand of prosthesis was selected at the discretion of the surgeon, and valve sizing was performed according to the guidelines provided by the manufacturers. The valve was sewn using interrupted horizontal pledgetted mattress sutures with 2/0 ethibond (ethicon). Reported complications included severe systemic infection causing death (n-2), uncontrollable bleeding causing death (n-1), and infection causing death (n-2). In conclusion, in light of this challenge, the authors believed that a preoperative strategy should be structured based on anticipating the risk of ppm and a proper calculation of the effective orifice area (eoa) in relation to annular size, so that implantation of the prosthesis can give the largest eoa index..
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02456 |
| MDR Report Key | 9900811 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-02 |
| Date Mfgr Received | 2020-03-31 |
| Date Added to Maude | 2020-03-30 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | ETHICON INC. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN |
| Generic Name | SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE |
| Product Code | GAT |
| Date Received | 2020-03-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |