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

Catalog Number	1151935
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Seroma (2069)
Date of Event	01/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no connection that can be made at this time between the reported post-operative complication (seroma) and any problem with the bard/davol xenmatrix ab graft used to treat the patient.The study subject has a complicated medical / surgical history that includes, diabetes, obesity, asthma, and multiple prior abdominal surgeries.The adverse event of seroma is classified by the clinician as being possible related to the study device and possible related to the procedure.No definitive conclusion can be made at this time.Seroma formation is a known inherent risk of surgery and is listed in the instructions-for-use, which are provided with the device, as a possible complication.Should additional information is provided, 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 or Problem Description
It was reported to davol that a patient who is part of a clinical study experienced a post operative seroma.On (b)(6) 2017 - the patient underwent implant of the xenmatrix ab graft during a complex multi-part procedure including a colectomy, end ileostomy, splenic flexure mobilization, subtotal gastrectomy, and gastrocolic takedown.The procedure was performed intraperitoneal with component separation technique.A fistula is noted to have been present at the time of this procedure.The size of the hernia defect was 30cm in length and 15cm 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 subxiphoid, epigastric, umbilical, infraumbilical and suprapubic space.The perimeter of the mesh was sutured with long-term absorbable monofilament with 33 fixation points.The midline fascia and skin were completely closed.A drain was inserted in the left upper quadrant, the left lower quadrant and the right lower quadrant.Hernia site wound classification noted as class iii (contaminated).The patient experienced acute blood loss anemia which was assessed as not device related and possibly procedure related.On (b)(6) 2017 - the patient was diagnosed with incisional cellulitis.This adverse event was assessed as not device related and possibly procedure related.The patient was started on antibiotics.On (b)(6) 2017 - the left upper quadrant drain removed.On (b)(6) 2017- the left lower quadrant drain removed.On (b)(6) 2017 - the right lower quadrant drain removed.On (b)(6) 2018 - the patient was admitted to the hospital with abdominal pain and diagnosed with a seroma.This adverse event was assessed as possibly device related and possibly procedure related.Ae required intervention and a drain was placed by interventional radiology.On (b)(6) 2018 - the patient was diagnosed with a linear ulceration.This adverse event was assessed as not device related and not procedure related.This emdr is submitted to report the formation of the post operative seroma as the event was assessed to be possible device related.

• 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: 7226342
• Report Number: 1213643-2018-00152
• Device Sequence Number: 13666622
• Product Code: PIJ
• UDI-Device Identifier: 00801741074301
• UDI-Public: (01)00801741074301
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K151177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other,stu
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/29/2018

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: 11/28/2017
• Device Catalogue Number: 1151935
• Device Lot Number: HUZJ0043
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2018
• Initial Report FDA Received Date: 01/29/2018
• 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: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 100