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

Catalog Number	5950060
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240); Disability (2371)
Date of Event	08/03/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol ventrio st (device #1) device may have caused or contributed to the reported event.The attorney alleges the patient underwent an additional surgery for recurrent hernia, lysis of adhesions.A later surgery was performed to partially remove the device.Recurrence and adhesions are a known inherent risk of surgery and are listed in the instructions-for-use a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Based on the limited information provided at this time, no conclusions can be made.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard/davol ventrio st (device #1).An additional emdr was submitted to represent the bard/davol ventrio st (device #2).Note: not returned.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2014: the patient underwent repair of an incisional hernia.A bard/davol ventrio st (device #1) was implanted in the patient during this repair.On (b)(6) 2015: the patient underwent surgery for recurrent incisional hernia repair.The physician performed extensive lysis of adhesions which were densely adherent to the mesh.The physician further noted that the small bowel was also densely adherent to the mesh.Although most of the small bowel was taken down (off the mesh), a portion still remained densely adherent to the mesh, and further dissection was not performed to avoid the risk of enterotomy.The patient was implanted with a bard/davol ventrio st (device #2) on (b)(6) 2015: the patient once again underwent surgery, whereby due to pneumoperitoneum, a portion of the mesh initially implanted on (b)(6) 2014 ("old mesh") was removed.The mesh implanted on (b)(6) 2015 was completely removed.The physician noted that portions of the small bowel had remained adherent to the old mesh.Serous fluid was evacuated.The patient is at high risk of mesh infection from the remaining piece of the old mesh, and at significant risk of additional reoperation.The patient continues to experience pain in the region of his operation, and may require additional surgery.The mesh implanted in the patient failed to reasonably perform as intended.The mesh caused serious injury and had to be surgically removed via invasive surgery, and necessitated additional invasive surgery to repair the hernia that the mesh was initially implanted to treat.The patient has been injured, sustained severe and permanent pain, suffering, anxiety, depression, disability, and impairment.

• Brand Name: VENTRIO ST
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 8097276
• Report Number: 1213643-2018-04136
• Device Sequence Number: 16641072
• Product Code: FTL
• UDI-Device Identifier: 00801741031557
• UDI-Public: (01)00801741031557
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/21/2018

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: 08/28/2015
• Device Catalogue Number: 5950060
• Device Lot Number: HUXH0701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability