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

Catalog Number UNKAA077

Device Problems Defective Device (2588); Folded (2630); Material Deformation (2976); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Granuloma (1876); Inflammation (1932); Hernia (2240); Injury (2348); Disability (2371); Fibrosis (3167)

Event Date 08/27/2013

Event Type  Injury  

Manufacturer Narrative

Based on the information provided we are unable to determine to what extent, if any the bard ventralex hernia patch mesh (device #1) 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 remove the ventralex hernia mesh patch which was noted by the operating surgeon to have "folded on itself." medical records are not available at this time, 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.No lot number has been provided; therefore a review of the manufacturing records is not possible at this time.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard ventralex mesh (device #1) implanted on (b)(6) 2009.An additional emdr was submitted to represent the bard composix l/p (device #2) implanted on (b)(6) 2013.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 a recurrent incisional abdominal hernia.A bard/davol ventralex hernia patch mesh (device #1) was implanted to repair the hernia defect.On (b)(6) 2013: the patient underwent an additional surgery to remove the ventralex hernia mesh patch which was noted by the operating surgeon to have "folded on itself." on (b)(6) 2013: the patient was implanted with a bard/davol composix l/p mesh (device #2) to repair a ventral hernia defect and to replace the failed ventralex hernia mesh patch from the patient's previous surgery.On (b)(6) 2015: the patient underwent an additional surgery to repair the hernia defect and to remove the composix l/p mesh.As reported, the operating surgeon noted that the composix mesh had tracked away from its position and pulled away from the left side completely and was "balled up along the right side." and the failed composix l/p was replaced with "another mesh device." 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 hernia patch and composix l/p hernia patch.

Manufacturer Narrative

Based on the information provided we are unable to determine to what extent, if any the bard ventralex hernia patch mesh (device #1) 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 remove the ventralex hernia mesh patch which was noted by the operating surgeon to have "folded on itself." medical records are not available at this time, 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.No lot number has been provided; therefore a review of the manufacturing records is not possible at this time.Addendum: h11: this supplemental mdr is submitted to document additional information provided and to correct gender and pma/510(k).Based on the additional information received, there is no change to initial determination, no conclusions can be made.Per medical records, about 4 years 1 month post implant of ventralex mesh (device #1), patient was diagnosed with adhesions, abdominal pain, fibrosis, granuloma, inflammation and material deformation thereby underwent repair with mesh removal.The instructions-for-use supplied with the device lists adhesions, inflammation and pain as a possible complications.This supplemental emdr represents mesh ¿ ventralex (device #1).An additional supplemental emdr was submitted to represent mesh ¿ composix l/p (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.H3 other text : not returned.

Event Description

The following was alleged by the patient's attorney: on (b)(6) 2009: the patient underwent surgery for repair of a recurrent incisional abdominal hernia.A bard/davol ventralex hernia patch mesh (device #1) was implanted to repair the hernia defect.On (b)(6) 2013: the patient underwent an additional surgery to remove the ventralex hernia mesh patch which was noted by the operating surgeon to have "folded on itself." on (b)(6) 2013: the patient was implanted with a bard/davol composix l/p mesh (device #2) to repair a ventral hernia defect and to replace the failed ventralex hernia mesh patch from the patient's previous surgery.On (b)(6) 2015: the patient underwent an additional surgery to repair the hernia defect and to remove the composix l/p mesh.As reported, the operating surgeon noted that the composix mesh had tracked away from its position and pulled away from the left side completely and was "balled up along the right side." and the failed composix l/p was replaced with "another mesh device." 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 hernia patch and composix l/p hernia patch.Addendum per additional information provided: on (b)(6) 2009 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with implant of ventralex mesh (device #1).Per operative notes, ¿fascial defect was identified in the midline.The fascial edges were dissected, and a medium ventralex mesh (device #1) was placed in the preperitoneal space and sutured.¿ (note: no product identifiers provided for both previously placed mesh and ventralex mesh).On (b)(6) 2013 - patient was diagnosed with chronic abdominal pain thereby underwent open repair with implant of composix l/p (device #2) and explant of ventralex mesh (device #1).Per operative notes, ¿some adhesions to the omentum, anterior abdominal wall and the previous mesh were removed.The ventralex patch appeared to be somewhat folded on itself and all previous meshes were removed.A composix l/p (device #2) was placed in the abdomen and sutured.Two rows of protacks were placed to secure the mesh.¿ on (b)(6) 2015 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with implant of ventralight st (device #3) and bard flat mesh (device #4) and explant of composix l/p (device #2).Per operative notes, ¿the composix l/p (device #2) was found to be pulled away from the left side and was balled up along the right side.Adhesions along the entire left side was removed.The mesh was removed completely with couple of protacks.Then, defect found in the rectus muscle was reapproximated with sutures.A ventralight st (device #3) and bard flat mesh (device #4) in the left upper quadrant covering the area of the defect and sutured.¿ attorney alleges that the patient had pain, bowel perforation, mesh shrinkage and hernia recurrence.

• Brand Name: MESH - VENTRALEX
• 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: 7252949
• MDR Text Key: 99567573
• Report Number: 1213643-2018-00240
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132441
• 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: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA077
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 40 YR
• Patient Sex: Male
• Patient Weight: 109 KG