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

Catalog Number	1161520
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Fistula (1862); Hematoma (1884); Unspecified Infection (1930); Inflammation (1932); Hernia (2240)
Date of Event	03/20/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the additional information received, no conclusions can be made.Per medical records review, post implant of xenmatrix, patient was diagnosed with infection, fistula, hernia recurrence, abscess, hematoma, adhesions, inflammation and abdominal pain thereby underwent repair.The instructions-for-use supplied with the device lists infection, hernia recurrence, adhesions and inflammation as possible complications.The warning section of the ifu states, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device".This emdr represents xenmatrix (device #2).Additional supplemental emdr's were submitted to represent mesh ¿ ventralex (device #1) & ventralight st mesh (device #3).Note: section a through f - the information provided by bd 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 bd.H3 other text: not returned.
Event or Problem Description
Per additional information provided: (b)(6) 2008 - patient was diagnosed with incisional umbilical hernia thereby underwent open repair with implant of ventralex mesh (device #1).Per operative notes, ¿the hernia sac was completely dissected.A ventralex mesh was placed in the peritoneal cavity and secured circumferentially with sutures.¿ (b)(6) 2015 - patient was diagnosed with recurrent umbilical hernia thereby underwent open repair with the explant of ventralex mesh (device #1).Per operative notes, ¿the old ventralex mesh was removed in its entirety.There was a recurrent umbilical hernia defect, elected to repair this primarily.The fascia seprafilm was placed over the abdominal contents and sutured.¿ (b)(6) 2015 - patient was diagnosed with fascial dehiscence thereby underwent open repair with the implant of xenmatrix mesh (device #2).Per operative notes, ¿the defect at the periumbilical region was too large and therefore placed a xenmatrix biologic mesh in an underlay fashion and tacked circumferentially with sutures.¿ (b)(6) 2015 - patient was diagnosed with abdominal wall abscess thereby underwent drainage of abdominal wall abscess.(b)(6) 2015 - patient was diagnosed with abdominal wound infection thereby underwent abdominal wound debridement and vac placement.Also, prescribed with medications for pain control.(b)(6) 2015 - patient was diagnosed with recurrent incisional hernia and hypertrophic abdominal wound scar thereby underwent open adhesiolysis and excision of hypertrophic fascial and dermal scar.Per operative notes, ¿the dermal scar was excised.The fascia was very thickened where the biological mesh had been placed and there was edema and inflammatory changes present.Adhesions were completely cleared and the fascia was re-approximated with sutures." (b)(6) 2015 - patient was diagnosed with abdominal pain and infected wound with abscess thereby underwent wound exploration with drainage of abscess.(b)(6) 2016 - patient was diagnosed with recurrent abdominal wall abscess thereby underwent excisional debridement of abdominal wall abscess.(b)(6) 2016 - patient was diagnosed with chronic recurring abdominal pain secondary to multiple incisional hernias thereby underwent laparoscopic repair with extensive adhesiolysis and implant of ventralight st mesh (device #3).Per operative notes, ¿once the anterior abdominal wall had been completely cleared of adhesions, a ventralight st mesh was placed into the abdominal cavity and secured with securestrap device.¿ (b)(6) 2016 - patient was diagnosed with wound hematoma thereby underwent incision with evacuation of hematoma and placement of drain.(b)(6) 2017 - patient was diagnosed with fistula and excision of mesh.(the op note was not provided in the medical records).(b)(6) 2017 - patient was diagnosed with infected mesh thereby underwent incision and drainage of anterior abdominal wall with removal of foreign body.Per operative notes, ¿some retained sutures were removed and there was a collection of purulence that was drained.Then, closed some of the scar tissue together using sutures.¿ (b)(6) 2017 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with implant of vicryl mesh.Per operative notes, ¿after dissection of dense scar tissues, a vicryl mesh was placed in an onlay fashion, and this was run up either side of the defect, anchoring it into available scar tissue and sutured." attorney alleged that the patient had abscess, adhesions, fistulae, infection, pain, hernia recurrence and emotional injuries.

• Brand Name: XENMATRIX
• Common Device Name: 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 20671922
• Report Number: 1213643-2024-094814
• Device Sequence Number: 8207954
• Product Code: FTM
• UDI-Device Identifier: 00801741031410
• UDI-Public: (01)00801741031410(17)151113(10)HUXK0733
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K140501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2024

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: 11/13/2015
• Device Catalogue Number: 1161520
• Device Lot Number: HUXK0733
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 118 KG