MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,stu report with the FDA on 2018-04-17 for XENMATRIX AB 1152025 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[105728035]
Based on the information provided we are unable to determine to what extent, if any, the xenmatrix ab graft may have caused or contributed to the events as alleged. The patient is an obese male, who 7 months post implant, developed wound issues with subsequent wound infection. The patient was treated in the hospital and released, the graft remains implanted. The adverse event of infection was assessed as possibly related to the study device and possibly related to the procedure. To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in (b)(4) 2016. Regarding infection the warning section of the instructions-for-use states, "this device is not indicated for the treatment of infection. If an infection develops, treat the infection aggressively. " a review of the manufacturing records was performed and found that the lot was manufactured to specification. All process steps were completed per manufacturing procedures, inspection procedures, as documented in work order and lot history records. Product passed all required inspections at both end product and subassembly levels. There was no rework or other manufacturing abnormalities that may have contributed to this complaint. If additional information is provided, a supplemental emdr will be submitted. Note: 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
[105728036]
It was reported to davol that a patient who is part of a clinical study experienced a post operative wound infection. On (b)(6) 2017 the subject patient underwent repair of large ventral hernia using the xenmatrix ab graft. The hernia site wound has been assessed as a class 1 (clean) site. A retro-rectus with component separation technique was performed. The graft was not trimmed and a 5cm graft overlap was maintained around the hernia defect. Absorbable monofilament suture was used to fixate the graft. The midline fascia and skin were fully closed. Four drains were inserted with two placed between the subcutaneous tissue and anterior fascia and the other two were placed over the mesh and underneath the fascia closure. On (b)(6) 2017 all drains were removed. On (b)(6) 2017 upon physical exam, the subject patient was noted to have "two areas of wound opening. On (b)(6) 2017 the subject patient was administered antibiotics for skin lesion and deep incisional wound infection/abscess. The patient underwent reoperation for aspiration and deep tissue cultures. Cultures revealed a bacterial infection of streptococcus pygenes. On (b)(6) 2017 the subject patient was discharged from the hospital. On (b)(6) 2017 the subject patient presented for post operative follow up visit. As reported, "skin over site is clean. Abdomen skin is clean/dry. Wound right upper quadrant was clean. Wound right lower quadrant clean. " these events (skin lesion / infection /abscess) were assessed by the clinician as possibly related to the study device and possibly related to the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2018-01108 |
| MDR Report Key | 7438103 |
| Report Source | HEALTH PROFESSIONAL,OTHER,STU |
| Date Received | 2018-04-17 |
| Date of Report | 2018-07-25 |
| Date of Event | 2017-11-18 |
| Date Mfgr Received | 2018-07-17 |
| Device Manufacturer Date | 2016-08-03 |
| Date Added to Maude | 2018-04-17 |
| 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 SUNDBERG |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XENMATRIX AB |
| Generic Name | PORCINE SURGICAL MESH |
| Product Code | PIJ |
| Date Received | 2018-04-17 |
| Model Number | NA |
| Catalog Number | 1152025 |
| Lot Number | HUAT2142 |
| Device Expiration Date | 2018-06-28 |
| 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. Hospitalization; 2. Required No Informationntervention | 2018-04-17 |