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

Catalog Number	1150606
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported the graft tore when being deployed down a 12 mm port.The subject product was discarded by the user facility and not returned for evaluation.Based on not having the sample returned for evaluation no conclusion can be made.However, the most probable root cause is the graft became damaged during trocar deployment.Regarding deployment the instructions-for-use state, "xenmatrix ab surgical graft may inhibit deployment through trocars during laparoscopic repairs.If the xenmatrix ¿ ab surgical graft cannot be easily deployed down the trocar, remove the trocar and insert the implant through the incision.Reinsert trocar." a review of the manufacturing records was performed and found that the lot was manufactured to specification.
Event or Problem Description
As reported, during a laparoscopic hiatal hernia repair while using xenmatrix ab graft, it "ripped" when deployed down a 12 mm port.The graft was removed and another xenmatrix ab graft was then used to complete the case without further issue.There was no patient injury.

• 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: 8771008
• Report Number: 1213643-2019-05855
• Device Sequence Number: 19342568
• Product Code: PIJ
• UDI-Device Identifier: 00801741074172
• UDI-Public: (01)00801741074172
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K151177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2021
• Device Catalogue Number: 1150606
• Device Lot Number: HUCW1444
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 07/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1