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

Catalog Number	5950090
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Death (1802); Obstruction/Occlusion (2422)
Date of Event	11/02/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
No conclusion can be made.The information as provided is limited.Additional information has been requested.However, it is reported that the details regarding the patient's postoperative course are unavailable at this time.Adhesion is a know inherent risk of surgery and is listed 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.When/if additional information is provided, this report will be updated.Sample not returned.
Event or Problem Description
It was reported that on (b)(6) 2019 the patient was implanted with bard ventrio st mesh and a non bard mesh.As reported the patient later passed away (date of death not provided).As reported the bowel had adhered to a mesh however the contact was unable to say if the mesh adhesions had caused or contributed to the patient's death.The patient's doctor is unavailable at this time to provide further details.
Additional Manufacturer Narrative
No conclusion can be made.The information as provided is limited.Additional information has been requested.However, it is reported that the details regarding the patient's postoperative course are unavailable at this time.Adhesion is a know inherent risk of surgery and is listed 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.When/if additional information is provided, this report will be updated.This is an addendum to document the receipt of additional information.The information provided indicates an elderly patient underwent a complicated procedure during which she was implanted with the ventrio st mesh and a non-bard onlay.The procedure was complicated by dense scar tissue.The rives stoppa procedure would not come together due to inflexibility.A ventrio st mesh was placed as a sublay (retro muscular).While closing, the scar tore and a non-bard onlay was used to augment the ventrio st mesh.As reported, there were adhesions found to the back of the ventrio st mesh at the outer perimeter.It was not identified how the ventrio st mesh came into contact with the bowel.It was alleged the cause of death to be related to obstruction.The patient's death certificate and/or autopsy report were not provided.While adhesions are a known inherent risk of surgery, no sample was returned for evaluation and a definitive conclusion cannot be made as to the possible cause of alleged adhesions to the mesh edge.This is an addendum to document the receipt of additional information.The additional information provided indicates that upon initial implant the posterior closure was incomplete, and the mesh was exposed to bowel.It appears that the issue may have presented due to an anatomical complication, advancing the patient condition and most likely not related to a malfunction or defect with the device.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.
Event or Problem Description
It was reported that on (b)(6) 2019 the patient was implanted with bard ventrio st mesh and a non bard mesh.As reported the patient later passed away (date of death not provided).As reported the bowel had adhered to a mesh however the contact was unable to say if the mesh adhesions had caused or contributed to the patient's death.The patient's doctor is unavailable at this time to provide further details.Addendum based on additional information provided by surgeon on (b)(6) 2019 ¿ the patient had a ¿6 x 6cm hernia, well defined neck of dense scar tissue.No surgical planes so novel ones created.Rives stoppa but due to inflexibility wouldn¿t come together.Therefore, right anterior compartment separation.Inadequate posterior sheath not closed.Bard ventrio st 35 x 24 mesh placed as sublay (retro muscular).On closing midline the scar tissue lateral to the rectus on the right tore open.Midline closure completed and ventrio st augmented with (onlay non-bard 20 x 15).Post operatively had a slow recovery with lots of fluid coming into the drains as would be expected as there was no seal between abdomen and subcutaneous fat except bridged mesh sandwich.Post operative ileus.Prolonged stay on hdu due to her chest.Atrial fibrillation.Post op type 2 respiratory failure.Hyponatraemia.Aortic stenosis." on (b)(6) 2019 - the patient was discharged.On (b)(6) 2019 - the "patient was readmitted via a and e.Vomiting.Abdominal pain.Hypotension.Repeat ct showed mildly raised white cell count.Crp 95.Rose to 390 on (b)(6) 2019.Fears over intra-abdominal sepsis.Hence laparotomy.As reported, "on (b)(6) 2019 a laparotomy by a colleague.He reported collection superficial to mesh sandwich.He reported dense adhesions around the entirety of the perimeter of the mesh.He divided these and left the abdomen open as a laparostomy.His intention was that it should be closed at a second procedure.There was no infection so it is unclear why this was done.Patient had one change of dressing in theatre.Then elected not for any further surgery, discharged from itu to palliative care.On (b)(6) 2019 - the patient's date of death.Per surgeon summary, "there were few planes at surgery and scarring lateral to the rectus was attenuated.She probably should have had a biological mesh in retrospect.The ventrio st would not form a fluid tight barrier between abdomen and skin.Hence subcutaneous collection.However, the cause of death was her small bowel obstruction from adhesions to the back of the ventrio st mesh at its perimeter.The seprafilm appears to have succeeded in resisting adhesions but for at the margin.If i had done the repeat surgery i would have placed an intraperitoneal biological mesh.Her chest was v poor post operatively after the initial operation and he had an extended stay.She was not in a good position to face the second operation.¿ addendum based on additional information provided by surgeon the surgeon states that during the implant procedure the mesh was sutured in place, mechanical fasteners were not used.Also stated was that the posterior closer was incomplete, there was no good posterior coverage, the implant was exposed to bowel.
Event or Problem Description
It was reported that on (b)(6) 2019 the patient was implanted with bard ventrio st mesh and a non bard mesh.As reported the patient later passed away (date of death not provided).As reported the bowel had adhered to a mesh however the contact was unable to say if the mesh adhesions had caused or contributed to the patient's death.The patient's doctor is unavailable at this time to provide further details.Addendum based on additional information provided by surgeon.(b)(6)2019: the patient had a ¿6 x 6cm hernia, well defined neck of dense scar tissue.No surgical planes so novel ones created.Rives stoppa but due to inflexibility wouldn¿t come together.Therefore, right anterior compartment separation.Inadequate posterior sheath not closed.Bard ventrio st 35 x 24 mesh placed as sublay (retro muscular).On closing midline the scar tissue lateral to the rectus on the right tore open.Midline closure completed and ventrio st augmented with (onlay non-bard 20 x 15).Post operatively had a slow recovery with lots of fluid coming into the drains as would be expected as there was no seal between abdomen and subcutaneous fat except bridged mesh sandwich.Post operative ileus.Prolonged stay on hdu due to her chest.Atrial fibrillation.Post op type 2 respiratory failure.Hyponatraemia.Aortic stenosis." on (b)(6) 2019: the patient was discharged.On (b)(6) 2019 - the "patient was readmitted via a and e.Vomiting.Abdominal pain.Hypotension.Repeat ct showed mildly raised white cell count.Crp 95.Rose to 390 on (b)(6)2019.Fears over intra-abdominal sepsis.Hence laparotomy.As reported, "(b)(6) 2019 a laparotomy by a colleague.He reported collection superficial to mesh sandwich.He reported dense adhesions around the entirety of the perimeter of the mesh.He divided these and left the abdomen open as a laparostomy.His intention was that it should be closed at a second procedure.There was no infection so it is unclear why this was done.Patient had one change of dressing in theatre.Then elected not for any further surgery, discharged from itu to palliative care.(b)(6) 2019: the patient's date of death.Per surgeon summary, "there were few planes at surgery and scarring lateral to the rectus was attenuated.She probably should have had a biological mesh in retrospect.The ventrio st would not form a fluid tight barrier between abdomen and skin.Hence subcutaneous collection.However, the cause of death was her small bowel obstruction from adhesions to the back of the ventrio st mesh at its perimeter.The seprafilm appears to have succeeded in resisting adhesions but for at the margin.If i had done the repeat surgery i would have placed an intraperitoneal biological mesh.Her chest was v poor post operatively after the initial operation and he had an extended stay.She was not in a good position to face the second operation.¿.
Additional Manufacturer Narrative
No conclusion can be made.The information as provided is limited.Additional information has been requested.However, it is reported that the details regarding the patient's postoperative course are unavailable at this time.Adhesion is a know inherent risk of surgery and is listed 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.When/if additional information is provided, this report will be updated.This is an addendum to document the receipt of additional information.The information provided indicates an elderly patient underwent a complicated procedure during which she was implanted with the ventrio st mesh and a non-bard onlay.The procedure was complicated by dense scar tissue.The rives stoppa procedure would not come together due to inflexibility.A ventrio st mesh was placed as a sublay (retro muscular).While closing, the scar tore and a non-bard onlay was used to augment the ventrio st mesh.As reported, there were adhesions found to the back of the ventrio st mesh at the outer perimeter.It was not identified how the ventrio st mesh came into contact with the bowel.It was alleged the cause of death to be related to obstruction.The patient's death certificate and/or autopsy report were not provided.While adhesions are a known inherent risk of surgery, no sample was returned for evaluation and a definitive conclusion cannot be made as to the possible cause of alleged adhesions to the mesh edge.Updated fields: a2, a3, b2 (date of death), b3, b4, b5, b6, g4, g7, h2, h6, h10.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 : sample not returned.

• 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: 9882447
• Report Number: 1213643-2020-03001
• Device Sequence Number: 2784789
• Product Code: FTL
• UDI-Device Identifier: 00801741031588
• UDI-Public: (01)00801741031588
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2020

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: 11/28/2020
• Device Catalogue Number: 5950090
• Device Lot Number: HUCX2366
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 06/12/2020; 07/13/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 07/08/2020; 07/24/2020
• 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: Death; Life Threatening; Required Intervention
• Patient Age: 82 YR