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 2018-04-18 for XENMATRIX AB 1152025 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[105765937]
There is no connection that can be made between the reported postoperative complication (seroma) and any problem with the xenmatrix ab graft used to treat the patient. The patient has a complicated medical / surgical history that includes postoperative complications of abdominal fluid collection, mrsa, abdominal abscess, abdominal fistula formation and multiple prior abdominal surgeries. Additionally, the implant procedure was complicated by a bowel resection and the presence of an enterocutaneous fistula the graft remains implanted. No definitive conclusion can be made at this time. Seroma formation is a known inherent risk of surgery and is identified in the adverse reaction section of the instructions-for-use as a potential complication. 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. 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
[105765938]
It was reported that a patient who is part of a clinical study has been diagnosed with a seroma. On (b)(6) 2017- the patient underwent the repair of a recurrent hernia and was implanted with a xenmatrix ab graft. During this procedure the patient also underwent the explant of a non davol mesh device that was implanted on (b)(6) 2014 and a bowel resection. Due to the nature of the procedure the wound classification has been considered to be class 3 (contaminated). An intraperitoneal technique with component separation technique was performed. There was a fistula present at the time of surgery. The xenmatrix ab graft was trimmed and a 5cm graft overlap was maintained around the hernia defect. Long-term absorbable monofilament suture was used to fixate the graft. The midline fascia and skin were completely closed. At the close of the procedure, the wound class was changed to a class 4 due to the ec fistula. Drains were placed in the subcutaneous left lower quadrant and the subcutaneous right lower quadrant. On (b)(6) 2017- the patient diagnosed with a seroma. The seroma has been assessed by the clinician as being possibly related to the study device and possibly related to the procedure. The seroma was considered a grade 3 with moderate severity. On (b)(6) 2017- the patient underwent the placement of two drains, one in the preperitoneal left lower quadrant and the intraperitoneal right upper quadrant to drain the seroma. The patient diagnosed with incisional cellulitis, and was treated with antibiotics. Per the clinician the cellulitis was not related to the study device. On (b)(6) 2017- the patient was diagnosed with an ileus. Per the clinician the ileus was not related to the study device. On (b)(6) 2017 - the subcutaneous right lower quadrant and the intraperitoneal drains were removed. On (b)(6) 2017 -the subcutaneous left lower quadrant and the preperitoneal left lower quadrant drains were removed. The seroma was recorded as recovered / resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2018-01109 |
| MDR Report Key | 7439400 |
| Report Source | HEALTH PROFESSIONAL,OTHER,STU |
| Date Received | 2018-04-18 |
| Date of Report | 2018-04-18 |
| Date of Event | 2017-09-29 |
| Date Mfgr Received | 2018-03-29 |
| Device Manufacturer Date | 2017-01-31 |
| Date Added to Maude | 2018-04-18 |
| 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 | 2018-04-18 |
| Model Number | NA |
| Catalog Number | 1152025 |
| Lot Number | HUAZ1252 |
| Device Expiration Date | 2018-12-28 |
| 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. Required No Informationntervention | 2018-04-18 |