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

Catalog Number	1201520
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	08/08/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported per clinical trial (b)(6): on (b)(6) 2017 - subject patient underwent robotic assisted technique for first time recurrent incisional umbilical hernia repair procedure.The size of hernia defect was 2.1cm x 2.2cm.A bard/davol phasix st mesh was placed in an underlay fashion intra-peritoneally with sutures.Facia and full skin closure was achieved using sutures and adhesive skin closure.On (b)(6) 2017 - subject patient diagnosed with post operative ileus with nausea/vomiting and placed with nasogastric (ng) tubing for decompression and the patient diet was advanced slowly.The patient was discharged from the hospital on (b)(6) 2017.Per the study clinician, the reported adverse event has been assessed as moderate in severity, possibly related to the study device and definitely related to the index procedure.The outcome for this ae is reported as recovered/resolved.On (b)(6) 2018 ¿ subject patient underwent physical examination and was diagnosed with a hernia recurrence.On (b)(6) 2019 - subject patient underwent recurrent incisional umbilical hernia repair procedure.Reportedly, the mesh was found to disintegrate during the adhesions removal from the anterior abdominal wall.The mesh was removed partially and replaced with a bard/davol ventralight st mesh.Patient was discharged on same day.Per the study clinician, the reported adverse event has been assessed as moderate in severity, possibly related to the study device and possibly related to the index procedure.The outcome for the ae is reported as recovered/resolved.
Additional Manufacturer Narrative
As reported, approximately one year post-implant of the phasix st mesh, the patient was diagnosed with hernia recurrence.During the revision procedure it was noted that the mesh was found to disintegrate during removal of adhesions.The mesh was removed partially.As reported, the ae is resolved.The clinician has assessed the patient¿s postoperative course as being ¿possibly¿ related to the study device and possibly related to the procedure, however, based on the information provided, no conclusion can be made.Hernia recurrence is a known inherent risk of surgery.The adverse reactions section of the instructions-for-use supplied with the device lists hernia recurrence as a possible complication.This mdr reports the ae of hernia recurrence.An additional mdr was submitted to report additional ae of post operative ileus.Not returned - partially explanted.
Event or Problem Description
Reported per clinical trial dvl-he-020: (b)(6)2017 - subject patient underwent robotic assisted technique for first time recurrent incisional umbilical hernia repair procedure.The size of hernia defect was 2.1cm x 2.2cm.A bard/davol phasix st mesh was placed in an underlay fashion intra-peritoneally with sutures.Facia and full skin closure was achieved using sutures and adhesive skin closure.(b)(6)2017 - subject patient diagnosed with post operative ileus with nausea/vomiting and placed with nasogastric (ng) tubing for decompression and the patient diet was advanced slowly.The patient was discharged from the hospital on (b)(6)2017.Per the study clinician, the reported adverse event has been assessed as moderate in severity, possibly related to the study device and definitely related to the index procedure.The outcome for this ae is reported as recovered/resolved.(b)(6) 2018 subject patient underwent physical examination and was diagnosed with a hernia recurrence.(b)(6) 2019 subject patient underwent recurrent incisional umbilical hernia repair procedure.Reportedly, the mesh was found to disintegrate during the adhesions removal from the anterior abdominal wall.The mesh was removed partially and replaced with a bard/davol ventralight st mesh.Patient was discharged on same day.Per the study clinician, the reported adverse event has been assessed as moderate in severity, possibly related to the study device and possibly related to the index procedure.The outcome for the ae is reported as recovered/resolved.
Additional Manufacturer Narrative
As reported, approximately one year post-implant of the phasix st mesh, the patient was diagnosed with hernia recurrence.During the revision procedure it was noted that the mesh was found to disintegrate during removal of adhesions.The mesh was removed partially.As reported, the ae is resolved.The clinician has assessed the patient¿s postoperative course as being ¿possibly¿ related to the study device and possibly related to the procedure, however, based on the information provided, no conclusion can be made.Hernia recurrence is a known inherent risk of surgery.The adverse reactions section of the instructions-for-use supplied with the device lists hernia recurrence as a possible complication.This mdr reports the ae of hernia recurrence.An additional mdr was submitted to report additional ae of post operative ileus.Addendum: h11: this is an addendum to the previously submitted mdr to report the correct lot release date.Review of manufacturing records confirms product was manufactured to specification.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 - partially explanted.

• Brand Name: PHASIX ST MESH
• 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: 14488233
• Report Number: 1213643-2022-00299
• Device Sequence Number: 5336326
• Product Code: OWT
• UDI-Device Identifier: 00801741095351
• UDI-Public: (01)00801741095351
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 06/21/2022

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: 09/28/2018
• Device Catalogue Number: 1201520
• Device Lot Number: HUAW1953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2022
• Supplement Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 05/24/2022
• Supplement Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2016
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 104 KG