MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-04-21 for EVARREST FIBRIN SEALANT PATCH UNK manufactured by Omrix Biopharmaceuticals Ltd.
[73415063]
This was spontaneous report from a physician's assistant via company (sales) representative, and concerns a patient of unspecified age and sex from the united states: local case id number (b)(4). The patient's height, weight and medical history were not reported. The patient was treated with evarrest fibrin sealant patch (batch unknown) initiated on (b)(6) 2017 to hold tissue after sutures would not hold (tissue sealing) during a perforated left ventrical procedure during (also reported as open heart surgery). Concomitant medications were not reported. On (b)(6) 2017, the patient experienced death, drug ineffective for unapproved indication and off label use. It was reported by the sales representative that during a perforated left ventrical procedure the surgeon was trying to suture the tissue with unknown suture. The tissue was badly damaged and the suture would not hold. They then attempted to use evarrest, but that patch blew off (drug ineffective for unapproved indication). They attempted to use another device, but it too blew off (details unspecified). The sales representative had been on the phone with physician's assistant during the procedure and was notified of the patient's passing, and that two devices had been used. There was no additional information available at the time of the call. The patient expired. Action taken with evarrest was not applicable. The patient had not recovered from drug ineffective for unapproved indication and off label use, and died from death on (b)(6) 2017. It was unspecified if an autopsy was performed. This report was serious (death, medically significant) and reportable (death). This case is linked to drug/device case 20170412374.
Patient Sequence No: 1, Text Type: D, B5
[73910523]
Additional information was received from a physician's assistant (pa) via company (sales) representative in response to a query on (b)(6) 2017. The reporter reported that the physician did not wish to speak with someone in medical affairs at ethicon. The physician did not believe that there was any deficiency with the product that contributed to the patient death. It was confirmed that two evarrest devices were used. The batch number for the first was confirmed as unknown, and the batch number for the second was (b)(4) (captured in aer numbers 20170424557/2017-00328). The first patch of evarrest stayed on 1. 5 hours then blew off due to excess blood pressure. The second patch came off right away due to excess blood pressure. The pa did not believe there was any defect with either device. This case, involving the same patient is linked to 2017-00328 and 20170424557.
Patient Sequence No: 1, Text Type: D, B5
[75829464]
Additional information was received from ethicon in the form of quality assurance on 09-may-2017 and 17-may-2017. Quality assurance results for batch (u07f162a) showed stability data of batch was reviewed. All results of long term up to t-6 were within specification. There was no evidence that there was an impact on the product. Results for batch (u13cj10g) were as followed: "ipc/ coa" (all test parameters met their specifications, no out of specifications or unusual results were reported); virus inactivation/ pasteurization (the virus inactivation/pasteurization performed according to required in "ws", no "oos" or unusual results were reported); filling into stedim bags: filling into stedim bags and freezing step parameters were met the specification and no out of specification or unusual results were reported and shipment to pfi:the shipment condition to pfi was according to the required shipment conditions, and met the specification. No oos or unusual results were reported. No nonconformance is related to batch u13cj10g. The drug substance was considered to be within the accepted parameters of production for release to processing into drug product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2017-00278 |
| MDR Report Key | 6513262 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-04-21 |
| Date of Report | 2017-05-09 |
| Date of Event | 2017-04-10 |
| Date Mfgr Received | 2017-04-10 |
| Date Added to Maude | 2017-04-21 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ETHICON, USA |
| Manufacturer Street | US ROUTE 22 |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082180707 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVARREST FIBRIN SEALANT PATCH |
| Generic Name | EVARREST FIBRIN SEALANT PATCH |
| Product Code | MZM |
| Date Received | 2017-04-21 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OMRIX BIOPHARMACEUTICALS LTD |
| Manufacturer Address | TEL HASHOMER, IS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Other | 2017-04-21 |