MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. XENMATRIX AB; PORCINE SURGICAL MESH

Catalog Number 1151935

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 01/06/2017

Event Type  Injury  

Manufacturer Narrative

There is no connection that can be made at this time between the reported postoperative complication (right sided pain near incision) and any problem / malfunction with the davol device used to treat the patient.No action was taken and the ae is reported to have resolved.Postoperative pain is a known inherent risk of surgery and the drains were still in place at the time the pain was reported.Based on the information provided a definitive conclusion cannot be made.It was noted that the device in question was implanted after the labeled expiration date.Since the manufacture of this lot the shelf life for the xenmatrix ab graft has been extended to 24 months based on stability data.As such the device was implanted within the current shelf life period and this would not be a contributory factor to the patient's postoperative complications.Should additional information be obtained, a supplemental emdr 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.Remains implanted.

Event Description

It was reported that a patient who is part of a clinical study had experienced postoperative pain.On (b)(6) 2016 the subject patient underwent an exploratory laparotomy, lysis of adhesions, excision of suture granulomata with implant of a xenmatrix ab graft.At the time of the procedure, the patient had a bacterial infection of the wound in which cultures revealed staphylococcus aureus.The procedure was not delayed for treatment.A recto-rectus with component separation technique was performed using an open method for cst.The xenmatrix ab was trimmed and a 5cm graft overlap was maintained around the hernia defect.The hernia was located in the epigastric area with suture fixation of the graft.The midline fascia and skin were completely closed.Drains were inserted in the right lower quadrant and the left lower quadrant.On (b)(6) 2016 the subject patient was discharged from the hospital.On (b)(6) 2017 subject patient presented with "intermittent stabbing, postoperative pain in the right side near incision." the right lower quadrant drain was removed during this visit.On (b)(6) 2017 the left lower quadrant drain was removed.The ae is indicated as resolved on (b)(6) 2017.This adverse event was assessed by the clinician as a grade1, mild ae that is possibly related to the device and possibly related to the procedure.No action was taken and the pain has resolved.

• Brand Name: XENMATRIX AB
• Type of Device: PORCINE SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: laura sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 7446173
• MDR Text Key: 106010568
• Report Number: 1213643-2018-01155
• Device Sequence Number: 1
• Product Code: PIJ
• UDI-Device Identifier: 00801741074301
• UDI-Public: (01)00801741074301
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,stu
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2015
• Device Catalogue Number: 1151935
• Device Lot Number: HUZA1974
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Weight: 93