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

Catalog Number 5950007

Device Problems Defective Device (2588); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Abscess (1690); Adhesion(s) (1695); Fistula (1862); Pain (1994); Hernia (2240); Disability (2371)

Event Date 06/11/2015

Event Type  Injury  

Manufacturer Narrative

Based on the information provided we are unable to determine to what extent, if any the bard device may have caused or contributed to the events as alleged by the patient¿s attorney.The information provided alleges that the, "patient underwent an additional surgery to repair the hernia defect and remove it." medical records were not provided and the description does not clearly define what "remove it" is referring to (example possible mesh explant, partial explant, or removal/repair of the hernia defect itself without explant of previously placed mesh).As such at this time, we have not identified this as reported device explant.Additionally, it is unclear at this time if the hernia defect repaired post implant of the mesh, was a recurrence of the original hernia defect or a new hernia defect, however, recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard device implanted on (b)(6) 2014 (device #2).An additional emdr was submitted to represent the bard device implanted on (b)(6) 2009 (device #1).The information provided by bard 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 bard.Not returned.

Event Description

The following was alleged by the patient's attorney: on (b)(6) 2009: the patient underwent surgery for repair of an incisional hernia.A bard/davol ventralex st hernia patch, reference number 5950007 and lot number huti1030 (device #1), was implanted to repair the hernia defect.On (b)(6) 2014: the patient underwent a second repair of an incisional hernia.A bard/davol ventralex st hernia patch, reference number 5950007 and lot number huyf1416 (device #2), was implanted to repair the hernia defect.On (b)(6) 2015: the patient underwent an additional surgery to repair the hernia defect and "remove it." as alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective ventralex st hernia patch.

Manufacturer Narrative

Based on the information provided we are unable to determine to what extent, if any the bard device may have caused or contributed to the events as alleged by the patient¿s attorney.The information provided alleges that the, "patient underwent an additional surgery to repair the hernia defect and remove it." medical records were not provided and the description does not clearly define what "remove it" is referring to (example possible mesh explant, partial explant, or removal/repair of the hernia defect itself without explant of previously placed mesh).As such at this time, we have not identified this as reported device explant.Additionally, it is unclear at this time if the hernia defect repaired post implant of the mesh, was a recurrence of the original hernia defect or a new hernia defect, however, recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication.Addendum: this supplemental emdr is submitted to document additional information provided.Based on the additional information received, there is no change to the initial determination, no conclusions can be made.Per medical records review, about 9 months post implant of ventralex st mesh, patient was diagnosed with abscess, adhesions, hernia recurrence and fistula thereby underwent repair with explant of mesh.The instructions-for-use supplied with the device lists fistula and adhesions as possible complications.Review of the manufacturing records was performed and found that the lot was manufactured to specification.This supplemental emdr represents ventralex st mesh (device #2).An additional supplemental emdr was submitted to represent another ventralex st mesh (device #1).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 Description

The following was alleged by the patient's attorney: (b)(6) 2009: the patient underwent surgery for repair of an incisional hernia.A bard/davol ventralex st hernia patch, reference number (b)(4) and lot number huti1030 (device #1), was implanted to repair the hernia defect.(b)(6)2014: the patient underwent a second repair of an incisional hernia.A bard/davol ventralex st hernia patch, reference number (b)(4) and lot number huyf1416 (device #2), was implanted to repair the hernia defect.(b)(6)2015: the patient underwent an additional surgery to repair the hernia defect and "remove it." as alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective ventralex st hernia patch.Addendum per additional information provided: (b)(6)2009 - patient was diagnosed with incisional hernia thereby underwent open repair with implant of ventralex st mesh (device #1).Per operative notes, "three small hernias were identified, two of which were joined in the midline.A small, more lateral hernial defect was closed internally.A ventralex st hernia patch (device #1) was placed in the defect and sutured." (b)(6)2014 - patient was diagnosed with incisional hernia thereby underwent open repair with implant of ventralex st mesh (device #2).Per operative notes, "the hernia sac was encountered and dissected down to the fascia and removed.A ventralex st patch (device #2) was placed on the defect and closed transversely." (note: there was no mention/visualization of device #1 during this procedure).(b)(6)2015 - patient was diagnosed with incarcerated incisional hernia and enterocutaneous fistula with abscess thereby underwent small bowel resection and explant of mesh (device #1 & #2).Per operative notes, "the hernia was opened and noted to have an enterocutaneous fistula in the abdominal cavity.The small bowel segment had fistulized to the patch (device #1 & #2).All the adhesions were freed up and closed." (note: it was unclear which mesh was explanted during this procedure).Attorney alleges that the patient had abscess, adhesions, bowel obstruction, bowel removal, fistulae, pain and emotional injuries.

• Brand Name: VENTRALEX ST
• Type of Device: 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: 7150660
• MDR Text Key: 95916826
• Report Number: 1213643-2017-01116
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2016
• Device Catalogue Number: 5950007
• Device Lot Number: HUYF1416
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 51 KG