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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRIO ST SURGICAL MESH Back to Search Results
Catalog Number 5950050
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Adhesion(s) (1695); Obstruction/Occlusion (2422); Post Operative Wound Infection (2446)
Event Date 06/24/2021
Event Type  Injury  
Manufacturer Narrative
As reported, post-implant of the ventrio st mesh, the patient experienced bowel obstruction and adhesions and underwent surgical intervention. Also reported was that the patient developed a superficial surgical site infection following the second procedure. Intraoperative photos provided from the second procedure did not assist in determining a root cause of the reported postoperative complications. Based on the information available, no conclusions can be made. To date, this is the only reported complaint from this manufacturing lot. Adhesion and infection are known inherent risks of surgery. The instructions-for-use (ifu) supplied with the device lists adhesions, and infection as possible complications. In regards to the infection, the warning section of the ifu states "if an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the mesh. An unresolved infection may require removal of the device. " note, the date of event is considered to be a best estimate as (b)(6) 2021. Should additional information be provided, a supplemental mdr will be submitted.
 
Event Description
As reported, the patient underwent an abdominal wall reconstruction and ventral hernia repair using a bard/davol ventrio st. Post implant, about two weeks later, the patient presented with bowel obstruction which required surgery. During the surgery, it was found that the omentum and several loops of small bowel were densely adhered to the mesh. The small bowel mesentery had volvulized around the adherent loops which was intervened quickly without any requirement for bowel resection. As reported, the patient remained hospitalized with an ileus and has developed a superficial surgical site infection.
 
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Brand NameVENTRIO ST
Type of DeviceSURGICAL 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 Key12195208
MDR Text Key262399128
Report Number1213643-2021-20187
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101920
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 06/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number5950050
Device Lot NumberHUEU0550
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2021
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 Treatment Data
Date Received: 07/20/2021 Patient Sequence Number: 1
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