MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-07-27 for XENMATRIX AB 1151935 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[81232099]
This initial mdr is being submitted as a result of a retrospective review of davol? S mdr decisions and the initial decision not to report the event is being revised to reflect updated company procedures. It was reported that post implant of a xenmatrix ab in conjunction with the use of a microcyn irrigation, due to an active abdominal wall infection, the patient? S output color changed from brown to a dark green color. The contacting surgeon originally suspected the color change was possibly an interaction of the xenmatrix ab and the microcyn. A review of the manufacturing records was performed and found that the lot was manufactured to specification with no anomalies noted. In addition, there have been no other complaints of this nature reported. This is a complex case and the reported conditions may have many multiple causes unrelated to the xenmatrix ab graft. While the cause for the color change in the patient? S drain output remains unknown, based on the information provided and our evaluation, there is no indication it was related to any interaction between the two devices, as originally suspected by the contact surgeon. With the limited information we are unable to determine if the xenmatrix ab may have contributed to the output color change. The update provided by the contacting surgeon noted that there was patient injury with no intervention was taken. Should additional information be provided, this report will be updated. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. Remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[81232100]
Contacting surgeon reported, a possible finding regarding the xenmatrix ab mesh and use of microcyn irrigation with the veraflow system. The xenmatrix ab mesh was placed in the sublay fashion with complete closure of the patient? S abdominal fascia. The veraflow system and use of xenmatrix mesh were used to treat patient? S chronic (b)(6) infection of the abdominal wall post explant of an unspecified infected mesh. The surgeon reports she left a jp drain over the sublay mesh while patient had the veraflow irrigation. The output of the jp turned from light brown to dark green color. Another physician initially thought the output to be succus entericus and cultured the output (it grew out candida and a few gram positive bacilli and moderate gram positive cocci in chains (likely (b)(6)). So this is definitely not succus. The contacting surgeon removed the drain prior to discharging patient to home with home health wound vac dressing change. Patient was readmitted this weekend with the home health rn reporting succus material seen at the midline during her first dressing change. The succus was not seen by the surgeon on call when examining the patient. The reporting surgeon thinks that the fluid over the mesh might be a chemical reaction between rifampin and minocycline from the mesh and microcyn from the veraflow system. The patient? S ct scan which did not show any retained fluid and fascia is completely intact. The contacting surgeon wanted to report this observation as it may have caused the patient a readmission and possibly an additional operation. An update provided by the contact surgeon, reported that the patient was doing fine with no intervention. In addition the surgeon had placed a piece of xenmatrix ab in a solution of microcyn to see if it would change color or have some reaction. She reported that she did not observe any change over time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2017-00467 |
| MDR Report Key | 6748971 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-07-27 |
| Date of Report | 2017-07-27 |
| Date of Event | 2016-08-28 |
| Date Mfgr Received | 2016-09-11 |
| Device Manufacturer Date | 2016-02-29 |
| Date Added to Maude | 2017-07-27 |
| 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 | ANDREW TOPOULOS |
| Manufacturer Street | 100 CROSSINGS BLVD. |
| Manufacturer City | WARWICK RI 02886 |
| Manufacturer Country | US |
| Manufacturer Postal | 02886 |
| Manufacturer Phone | 4018258495 |
| Manufacturer G1 | BARD SHANNON LIMITED -3005636544 |
| Manufacturer Street | SAN GERONIMO INDUSTRIAL PARK LOT #1, ROAD #3, KM 79.7 |
| Manufacturer City | HUMACAO PR 00791 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00791 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XENMATRIX AB |
| Generic Name | PORCINE SURGICAL MESH |
| Product Code | PIJ |
| Date Received | 2017-07-27 |
| Model Number | NA |
| Catalog Number | 1151935 |
| Lot Number | HUAN0730 |
| Device Expiration Date | 2018-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DAVOL INC., SUB. C.R. BARD, INC. |
| Manufacturer Address | 100 CROSSINGS BLVD. WARWICK RI 02886 US 02886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-07-27 |