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 2018-01-24 for XENMATRIX AB 1152020 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[98135434]
There is no connection that can be made at this time between the reported post-operative complications (seroma, wound dehiscence) and any problem with the bard/davol xenmatrix ab graft used to treat the patient. As reported the graft was implanted into a contaminated environment and post implant the patient was hospitalized with pneumonia. The study subject is an elderly patient with a complicated medical / surgical history that includes, post operative infections, diabetes, obesity, and prior abdominal wall incisions / surgeries. The adverse events of seroma and wound dehiscence are classified by the study clinician as being possible related to the study device and definitely related to the procedure. The outcome is reported to be recovering / resolving, the graft remains implanted at this time. No definitive conclusion can be made at this time. Seroma formation is a known inherent risk of surgery and is listed in the instructions-for-use, which are provided with the device, as a possible complication. Should additional information is provided, a supplemental emdr will be submitted. This emdr documents information associated to the bard/davol xenmatrix ab graft, an additional emdr was submitted to document information associated to the bard/davol ventralight st hernia patch. 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
[98135435]
It was reported to davol that a patient who is part of a clinical study experienced a post operative seroma and wound dehiscence. On (b)(6) 2016 - the patient underwent exploratory laparotomy with ventral hernia repair with implant of bard/davol ventralight st hernia patch (this procedure was prior to the (b)(6) clinical study. ) on (b)(6) 2016 - the patient underwent surgery for incision and drainage of abdominal wall abscess due to surgical site infection/abscess. On (b)(6) 2017 - the patient was implanted with the xenmatrix ab graft during a hernia repair procedure. The hernia site classification is noted as a class iii (contaminated). An intraperitoneal without component separation technique was performed. The defect measured 12 cm in length and 8 cm in width. The graft was trimmed and a 5 cm graft overlap was maintained around the hernia defect. This was a midline hernia located in the umbilical and infraumbilical area. A long-term absorbable monofilament suture was used with 15 fixation points. The previously implanted bard ventralight st hernia patch was explanted during this procedure. Two drains were inserted in the left lower quadrant and one in the right lower quadrant. On (b)(6) 2017 - subcutaneous drain placed in the right lower quadrant was removed. On (b)(6) 2017 - the patient was discharged from the hospital. On (b)(6) 2017 - retro-rectus drain placed in the left lower quadrant was removed. On (b)(6) 2017 - the patient was diagnosed with pneumonia and treated with intravenous "vanc/ctx" in emergency department and then transitioned to levofloxacin to be received orally for a total of 7 days on (b)(6) 2017 - the patient was discharged from hospital after being treated for pneumonia. On (b)(6) 2017 - subcutaneous drain placed in the left lower quadrant was removed. On (b)(6) 2017 - pink serous drainage was noted at the incision site. On (b)(6) 2017 the patient experienced a seroma and wound dehiscence. Two small openings with serous drainage and openings were packed, no action was taken with the study device, which remains in vivo. The adverse events of seroma and wound dehiscence are classified by the clinician as being possible related to the study device and definitely related to the procedure. The outcome is reported to be recovering / resolving.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2018-00120 |
| MDR Report Key | 7216409 |
| Report Source | HEALTH PROFESSIONAL,OTHER,STU |
| Date Received | 2018-01-24 |
| Date of Report | 2018-01-24 |
| Date of Event | 2017-12-24 |
| Date Mfgr Received | 2017-12-28 |
| Device Manufacturer Date | 2016-12-30 |
| Date Added to Maude | 2018-01-24 |
| 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 | 2018-01-24 |
| Model Number | NA |
| Catalog Number | 1152020 |
| Lot Number | HUAY2190 |
| Device Expiration Date | 2018-11-28 |
| 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 | 2018-01-24 |