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

Catalog Number 1151928

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 08/17/2016

Event Type  Injury  

Manufacturer Narrative

There is no connection that can be made at this time between the reported postoperative complication (mild pain) and any problem / malfunction with the davol device used to treat the patient.Per the surgeon the pain is most likely attributable to the muscle release that was done as part of the hernia repair.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.As such the device was implanted within the current expiration period and this would not be a contributory factor to the patient 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 is experiencing mild postoperative pain.On (b)(6) 2016 - the patient underwent implant of the xenmatrix ab mesh, during a complex multi-part procedure including lysis of adhesions to remove bowel obstruction, excision of mass, removal of an unknown synthetic previously placed mesh and debridement.The procedure was performed retro-rectus without component separation technique.The size of the hernia defect was 26cm in length and 12cm in width.As reported, it was necessary to trim the xenmatrix ab graft and there was a 5cm graft overlap maintained around the hernia defect.The hernia location was midline and involved the umbilical, suprapubic, epigastric and infraumbilical space.The perimeter of the mesh was sutured with long-term absorbable monofilament with 7 fixation points.The midline fascia and skin were completely closed.Three drains were inserted in the retro-rectus left lower quadrant, subcutaneous right upper quadrant and the subcutaneous left upper quadrant.On (b)(6) 2018 - the patient present for visit and was asymptomatic.There was no evidence of hernia or recurrence and the patient reported mild right sided pain, which has been present and unchanged since operation.The patient continues to wear abdominal binder as this helps with her mild pain.Per the surgeon the pain is most likely attributable to the muscle release that was done as part of the hernia repair.The patient adverse event of right sided pain has been reported and assessed as possibly device related "as we can't completely rule this out" and definitely procedure related.As reported the patient is "doing great and continues to wear the abdominal binder." no additional treatment has been reported.The outcome is reported as recovering/resolving.

• 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: 7397526
• MDR Text Key: 104406368
• Report Number: 1213643-2018-00895
• Device Sequence Number: 1
• Product Code: PIJ
• UDI-Device Identifier: 00801741074271
• UDI-Public: (01)00801741074271
• 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: Health Professional
• Type of Report: Initial
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2015
• Device Catalogue Number: 1151928
• Device Lot Number: HUZB1913
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2015
• 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: 66 YR
• Patient Weight: 98