MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,study report with the FDA on 2018-06-26 for XENMATRIX AB 1152020 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[112351540]
As reported the xenmatrix ab graft was implanted into a compromised environment, which included an ecoli infection, a fistula and necrotic tissue around the hernia defect. While the clinician has stated that the hernia recurrence is "definitely related to the device" it should be noted that only a 2cm overlap was maintained due to the necrotic tissue around the hernia defect. It appears that the patient's compromised health was a contributing factor to the issues that presented post implant. However, at this time, no definitive conclusion has been be made. To date this is the only reported complaint for this manufacturing lot of 30 units released for distribution in august, 2016. Regarding recurrence and infection the warning section of the instructions-for-use states, "to minimize recurrences when repairing hernias, the graft should be large enough to provide sufficient overlap beyond the margins of the defect on all sides" and "this device is not indicated for the treatment of infection. If an infection develops, treat the infection aggressively. " a manufacturing review that included review of sterility records was performed and found that the lot was manufactured to specification. Should additional information be 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
[112351541]
The following is associated to a patient who is part of a clinical study. On (b)(6) 2016 - the patient underwent an intraperitoneal repair with component separation technique to repair the hernia (subxiphoid) using a xenmatrix ab graft. As noted the wound site was contaminated with a bacterial wound infection (ecoli) prior to implant of the study device. Explant of a previously place non davol parietex mesh was performed at this time. A fistula is noted to have been present at the time of the procedure and the midline fascia was not closed at this time due to necrotic tissue around hernia defect. A vacuum assisted closure was performed. It is noted is that a 5cm overlap of the defect with the graft was not maintained and only a 2cm overlap was maintained due to necrotic tissue around the hernia defect. The wound never initially healed postoperatively and was assessed by the clinician as possibly related to the study device and possibly related to the procedure. On (b)(6) 2016 - (b)(6) 2017 - the patient was diagnosed and treated for, c-diff toxin, uti, klebsiella bacteria, uti with bacteria with ecoli, and vre infected abdominopelvic hematoma. These diagnosis have been assessed by the clinician as not related to the study device. On (b)(6) 2017 - during a follow up visit it is noted that the wound is granulating, healing by secondary intention with no cellulitis. On (b)(6) 2018 - the patient was diagnosed with a wound infection. This has been assessed by the clinician as possibly related to the study device and possibly related to the procedure. On (b)(6) 2018 - during a follow up visit erythema is noted with opening at incision site. 2 x 6cm area that remains with granulation tissue that has not epithelialized. The patient was also diagnosed with a hernia recurrence, which has been assessed as definitely related to the device and definitely related to the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2018-02208 |
| MDR Report Key | 7638452 |
| Report Source | OTHER,STUDY |
| Date Received | 2018-06-26 |
| Date of Report | 2018-06-26 |
| Date of Event | 2018-05-18 |
| Date Mfgr Received | 2018-06-08 |
| Device Manufacturer Date | 2016-08-24 |
| Date Added to Maude | 2018-06-26 |
| 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 | 2018-06-26 |
| Model Number | NA |
| Catalog Number | 1152020 |
| Lot Number | HUAT2141 |
| Device Expiration Date | 2018-06-28 |
| 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 | 2018-06-26 |