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 2017-02-10 for XENMATRIX AB UNKAA105 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[67155499]
As requested the surgeon was provided with a doctor to doctor consult. Based on information obtained following the consult it appears that the patient was experiencing an exaggerated foreign body response, it also appears that the graft was not placed flat which could contribute to the reported incorporation of the graft. The precaution section of the ifu states, place device in maximum possible contact with health, well vascularized tissue to promote cell ingrowth and tissue remodeling. Inflammation and allergic reaction or hypersensitivity to device materials are listed in the adverse reaction section of the ifu as possible complications. Multiple attempts have been made to obtain the product code and lot number of the xenmatrix ab graft, however the user was not willing to provide this information. Without a lot number a review of the manufacturing records is not possible. Additionally, the explanted graft was not returned for evaluation. Based on the information provided, no definitive conclusion can be made as to why the graft did not incorporate and became encapsulated. Should additional details be provided, a supplemental mdr will be submitted. 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. Not returned.
Patient Sequence No: 1, Text Type: N, H10
[67155500]
It was reported that on (b)(6) 2016 the patient underwent a breast reconstruction procedure in which the surgeon used the xenmatrix ab in the abdomen as an overlay graft on the rectus sheath to reinforce a tram/diep. The surgeon reports the graft increased in thickness since implant and had not incorporated. The surgeon also reports inflammation and the patient is complaining of severe pain. A portion of the graft was sent for culture with results showing no infection. During a reoperation procedure it was noted that the graft had become encapsulated and the graft was removed. The surgeon contacted davol and requested a surgeon consult regarding this case.
Patient Sequence No: 1, Text Type: D, B5
[113294199]
This an addendum to the initial mdr to document the receipt of maude event report (mw5069553). Multiple requests for additional information were made to the reporter, who responded that she has been unavailable and would respond to the request when possible. Should additional information be provided a supplemental mdr will be submitted. 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.
Patient Sequence No: 1, Text Type: N, H10
[113294200]
As reported by the surgeon: it was reported that on (b)(6) 2016 the patient underwent a breast reconstruction procedure in which the surgeon used the xenmatrix ab in the abdomen as an overlay graft on the rectus sheath to reinforce a tram/diep. The surgeon reports the graft increased in thickness since implant and had not incorporated. The surgeon also reports inflammation and the patient is complaining of severe pain. A portion of the graft was sent for culture with results showing no infection. During a reoperation procedure it was noted that the graft had become encapsulated and the graft was removed. The surgeon contacted davol and requested a surgeon consult regarding this case. Addendum per maude event report (mw5069553) as reported by the patient: "xen ab was used in bilateral reconstruction with tram flap and umbilical hernia repair. Mesh has hardened into a "bone like" matter and has caused excruciating pain and disability. Subsequent surgeries performed and extensive lifestyle limitations has occurred
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2017-00095 |
| MDR Report Key | 6322597 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-02-10 |
| Date of Report | 2017-06-22 |
| Date Mfgr Received | 2017-05-31 |
| Date Added to Maude | 2017-02-10 |
| 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 | LAURA BERG |
| Manufacturer Street | 100 CROSSINGS BLVD. |
| Manufacturer City | WARWICK RI 02886 |
| Manufacturer Country | US |
| Manufacturer Postal | 02886 |
| Manufacturer Phone | 4018258462 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XENMATRIX AB |
| Generic Name | PORCINE SURGICAL MESH |
| Product Code | PIJ |
| Date Received | 2017-02-10 |
| Model Number | NA |
| Catalog Number | UNKAA105 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Required No Informationntervention | 2017-02-10 |