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 Problems Bacterial Infection (1735); Pain (1994); Seroma (2069)

Event Date 12/23/2017

Event Type  Injury  

Manufacturer Narrative

There is no connection that can be made at this time between the reported post-operative complications (infected seroma) and any problem with the bard/davol xenmatrix ab graft used to treat the patient.As reported the graft was implanted into a contaminated environment and the patient was later diagnosed with an infected seroma.The adverse event of infected seroma was classified by the clinician as being possible related to the study device and possibly related to the procedure.No definitive conclusion can be made at this time.The patient's treatment continues at this time, and the graft remains implanted.Regarding infection the warning section of the instructions-for-use states, "this device is not indicated for the treatment of infection.If an infection develops, treat the infection aggressively.Additionally, seroma formation is a known inherent risk of surgery and is identified in the adverse reaction section of the instructions-for-use as a potential complication.Should additional information is provided, a supplemental emdr will be submitted.This emdr documents information associated to the bard/davol xenmatrix ab graft, an additional emdr was submitted to document information associated to the bard/davol kugel mesh.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 to davol that a patient who is part of a clinical study experienced a post operative infected seroma.On (b)(6) 2002 - the patient was implanted with a bard/davol kugel mesh for the repair of a recurrent midline hernia.On (b)(6) 2017 - the patient underwent the implant of a xenmatrix ab graft and colon resection, during this procedure a previously placed "kugel" mesh was explanted.The hernia site wound classification is listed as being a class iv (dirty-infected).The patient is noted to have a bacterial infection with (b)(6), escherichia coli, enterococcus avium, and bacteroides fragilis.An intraperitoneal with component separation technique was used.The procedure was performed in open fashion and a fistula is noted to have been present at the time of surgery.The size of the hernia defect was 30cm in length and 13cm in width.The xenmatrix ab graft was trimmed and a 5cm overlap was maintained around the hernia defect.The hernia was located in the midline abdomen and involved the subxiphoid, epigastric, umbilical, infraumbilical and suprapubic areas.The mesh was sutured with long-term absorbable monofilament sutures using 31 fixation points.The midline fascia and skin were completely closed.Drains were inserted into the left upper quadrant, left lower quadrant, and the right lower quadrant.On (b)(6) 2017 - the patient was diagnosed with acute blood loss anemia.This adverse event was assessed as not related to the device (xenmatrix ab) and possibly procedure related.The patient received 2 units of packed red blood cells.On (b)(6) 2017 the patient was diagnosed with dehydration.This adverse event was assessed as not related to the device (xenmatrix ab) and not related to the procedure.The patient received iv fluids and monitoring.On (b)(6) 2017 - the patient was admitted to the hospital with abdominal pain and was diagnosed with a surgical site infection (ssi), iv and oral antibiotics were administered and a drain was placed.The ssi is noted to be in the deep tissue layer with purulent drainage.An infected seroma is noted to have been present.The bacterial growth cultured to be streptococcus anginosus.An abdominal ct scan was performed, a drain was placed, and the patent received 1 unit of packed red blood cells.Treatment continues.The adverse event of infected seroma was classified by the clinician as being possible related to the study device and possibly related to the procedure.

• 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: 7229085
• MDR Text Key: 98628945
• Report Number: 1213643-2018-00160
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2017
• Device Catalogue Number: 1151935
• Device Lot Number: HUZJ0043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 76