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

Catalog Number	1162025
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Abscess (1690)
Date of Event	01/29/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Alleged per clinical trial (b)(6): on (b)(6) 2014, the patient underwent first time recurrent incisional midline open hernia (20 cm x 8 cm) repair procedure, during which a xenmatrix surgical graft was trimmed and placed in inlay fashion intra-peritoneally using anterior component separation technique (cst) method, fixated using sutures.Fascia was achieved using vicryl interrupted sutures and full skin closure was achieved using sutures.Concomitant procedure includes panniculectomy, lysis of adhesions and bowel resection.The patient was discharged to home on (b)(6) 2014.On (b)(6) 2015, the patient was diagnosed with an abscess and was admitted into the hospital.The patient was discharged the next day on (b)(6) 2015.The adverse event was resolved on (b)(6) 2015.The ae is clinically assessed to be possibly related to the study device and not related to the procedure.This has been assessed as a serious adverse event of moderate severity.The reported adverse event meets the definition of an sae (serious adverse event) and does not meet the definition of uade (unidentified adverse device event).
Additional Manufacturer Narrative
As reported, about 10 months post-implant, the patient was diagnosed with abscess and was hospitalized.The clinician has assessed the patient¿s postoperative course as being ¿possibly¿ related to the study device and not related to the procedure, however, based on the information provided, no conclusion can be made.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in january, 2014.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.Not returned - remains implanted.
Event or Problem Description
Alleged per clinical trial dvl-he-020: on (b)(6) 2014, the patient underwent first time recurrent incisional midline open hernia (20 cm x 8 cm) repair procedure, during which a xenmatrix surgical graft was trimmed and placed in inlay fashion intra-peritoneally using anterior component separation technique (cst) method, fixated using sutures.Fascia was achieved using vicryl interrupted sutures and full skin closure was achieved using sutures.Concomitant procedure includes panniculectomy, lysis of adhesions and bowel resection.The patient was discharged to home on (b)(6) 2014.On 29-jan-2015, the patient was diagnosed with an abscess and was admitted into the hospital.The patient was discharged the next day on (b)(6) 2015.The adverse event was resolved on 22-apr-2015.The ae is clinically assessed to be possibly related to the study device and not related to the procedure.This has been assessed as a serious adverse event of moderate severity.The reported adverse event meets the definition of an sae (serious adverse event) and does not meet the definition of uade (unidentified adverse device event).
Additional Manufacturer Narrative
As reported, about 10 months post-implant, the patient was diagnosed with abscess and was hospitalized.The clinician has assessed the patient¿s postoperative course as being ¿possibly¿ related to the study device and not related to the procedure, however, based on the information provided, no conclusion can be made.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 33 units released for distribution in january, 2014.Addendum: h11: this is an addendum to the previously submitted mdr to correct unique identifier (udi) # & pma / 510(k) # and to update imdrf b code.Corrected fields: g4 (pma/510(k) #), d.4 (unique identifier (udi) #).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.

• Brand Name: XENMATRIX
• Common Device Name: PORCINE 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: 15151137
• Report Number: 1213643-2022-00562
• Device Sequence Number: 5782064
• Product Code: FTM
• UDI-Device Identifier: 00801741031465
• UDI-Public: (01)00801741031465
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K140501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2022

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: 01/28/2016
• Device Catalogue Number: 1162025
• Device Lot Number: HUXL1249
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2014
• 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: Hospitalization
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 98 KG