MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 XENMATRIX AB; SURGICAL MESH

Catalog Number	1151525
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Hernia (2240); Obstruction/Occlusion (2422); Fluid Discharge (2686)
Date of Event	01/01/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
No conclusions can be made.As reported, patient had a complex medical history with multiple implants and surgical procedures.No medical records, autopsy report, or death certificate have been provided.Review of manufacturing records for the xenmatrix ab implants used to treat the patient confirmed the products were manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 31 units.Note, the actual date of death and the date of event were not reported in the report sent to bd.We have documented these required date fields with a best estimate.This mdr represents the xenmatrix ab (device #1).An additional mdr was submitted to represent the xenmatrix ab (device #2).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.
Event or Problem Description
Per medwatch report (mw5167617), "alleged event: limited information was reported through a legal event that a patient was implanted with 1st strattice on (b)(6) 2016 and 2nd strattice on (b)(6) 2017.The form also indicates that on an unspecified date, the strattice implant had been removed or revised.No information was provided on the indication for the initial surgery or the reason for the removal or revision.Patient has died on (b)(6) 2022 and therails oe is no further detn death causality.This record captured 1st strattice.On (b)(6) 2025, (b)(6) received notification from legal that the plaintiff profile form was received associated with this event.As per the ppf form, the patient was born with an abdominal wall defect (gastroschisis), who underwent a ventral hernia surgery and was implanted with a strattice device lot sp100381-101 on (b)(6) 2016.The patient underwent an open ventral incisional hernia repair with biological mesh on (b)(6) 2017.The patient was implanted with a second strattice device lot sp100537-078 on the same date.The patient then underwent an incisional/ventral hernia repair with biologic mesh on (b)(6) 2018 and implanted with a third strattice device lot sp100595." the patient then underwent an open ventral incisional hernia repair with mesh on (b)(6) 2018 and implanted with a nonabbvie device, xenmatrix lot hucr0748.The mesh was revised due to recurrent ventral hernia repair with biologic mesh on (b)(6) 2018 and implanted was a second non-abbvie device, bard mesh lot #hucq0919.The mesh was revised on (b)(6) 2022 due to open repair of recurrent ventral incisional hernia with biological mesh, abdominal re-entry for correction of re-herniation and implanted with a fourth strattice device lot sp200312-045." the form lists the conditions that were treated were open ventral incisional hernia repair with biologic strattice mesh on or about (b)(6) 2016.The patient also underwent an open ventral incisional hernia repair with biologic mesh (strattice) on or about(b)(6) 2017.The patient was treated for incisional/ ventral hernia repair with biologic mesh (strattice) between (b)(6) 2018.The patient underwent open ventral incisional hernia repair with mesh (recurrent); at bedside serous sanguinous oozing around left jp drain between (b)(6) 2018 and (b)(6) 2018.The patient was treated for recurrent ventral hernia repair with biologic mesh on or about (b)(6) 2018.The patient was seen for abdominal pain between 2018 and (b)(6) 2022.The patient was treated for bowel obstruction between approximately 2017-2018.The patient received treatment for abdominal pain/adhesions between (b)(6) 2016 and (b)(6) 2022.The patient was seen for bowel obstruction, abdominal pain, adhesions between (b)(6) 2016 and (b)(6) 2022.The patient was seen for hernia symptoms from approximately 2018 to (b)(6) 2022.The patient was treated open repair of recurrent incisional hernia with biologic mesh (strattice); abdominal re-entry for correction of reherniation between (b)(6) 2022 and (b)(6) 2022.The patient received post-op rehab between 2018-2019."this report reflects information received by fda in the form of a notification per 803.22 (b)(2)".Reference report: mw5167618.Lot #: hucr0748".

• Brand Name: XENMATRIX AB
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 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 ; 8005566756
• MDR Report Key: 21761314
• Report Number: 1213643-2025-00294
• Device Sequence Number: 18345870
• Product Code: PIJ
• UDI-Device Identifier: 00801741074257
• UDI-Public: (01)00801741074257(17)200628(10)HUCR0748
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K133223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2025

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: 06/28/2020
• Device Catalogue Number: 1151525
• Device Lot Number: HUCR0748
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/20/2018
• 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; Death
• Patient Sex: Unknown