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

Catalog Number	1152025
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Seroma (2069)
Date of Event	09/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided we are unable to determine to what extent if any, the bard device may have caused or contributed to the patient post operative pain and seroma.The adverse events were assessed as possibly related to the device and definitely related to the procedure.Seroma is a known inherent risk of surgical procedures and is listed in the adverse reaction section of the ifu as a possible complication.Should additional information be reported regarding the patient's condition, a supplemental mdr 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.Device remains implanted.
Event or Problem Description
The following was reported and is associated with the (b)(4).On (b)(6) 2016 - the patient was implanted with a bard xenmatrix ab graft for the treatment of a recurrent ventral incisional hernia.The procedure included a partial mesh (unknown) excision and extensive lysis of adhesions.The unknown mesh was removed due to the extent of the adhesions.The existing hernia repair was performed with a retro-rectus technique without component separation.The hernia defect was measured with a length of 25cm and width of 14cm.The xenmatrix ab graft was trimmed prior to placement.There was a graft overlap of at least 5cm around the hernia defect.The hernia location is listed to have encompassed the subxiphoid, epigastric, umbilical and infraumbilical area.The graft was suture fixated.A surgical drain was placed in the right lower quadrant, recto-rectus space.On (b)(6) 2016- the patient presented for her three month postop visit.A 3cm x 3cm, soft non tender seroma below the umbilicus was revealed.There was no medical / surgical intervention.The seroma was assessed as possibly related to the device and definitely related to the procedure.On (b)(6) 2016 - the patient was diagnosed with abdominal pain of moderate severity.The pain was assessed as possibly related to the device and possibly related to the procedure.There was no action taken and no intervention required.There was no mention of a seroma.On (b)(6) 2016 - the patient was seen at the six month postop visit.The patient was assessed to have a well healed midline scar.Non tender to touch.The seroma had resolved.

• Brand Name: XENMATRIX AB
• Common Device Name: PORCINE SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 6479687
• Report Number: 1213643-2017-00228
• Device Sequence Number: 13775239
• Product Code: PIJ
• UDI-Device Identifier: 00801741074288
• UDI-Public: (01)00801741074288(17)171228(10)HUZL0467
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K151177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,other,stu
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/28/2017
• Device Catalogue Number: 1152025
• Device Lot Number: HUZL0467
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2017
• Initial Report FDA Received Date: 04/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Weight: 64