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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. VENTRALEX ST SURGICAL MESH Back to Search Results
Catalog Number 5950008
Device Problems Signal Artifact/Noise (1036); False Positive Result (1227); Device-Device Incompatibility (2919)
Patient Problem No Code Available (3191)
Event Type  malfunction  
Manufacturer Narrative
Based on the information provided a pet scan in that area of the ventralex st lit up the entire implant. It appears that the imaging anomaly was due to the implant at the site. There are reports in literature that the inflammatory process associated with mesh healing may mimic malignancy on pet. Plypropylene products, including hernia mesh such as ventraex st may light up on a pet scan due to higher uptake of the tracer. A review of the manufacturing records was performed and found that the lot was manufactured to specification. This emdr addresses the issue associated with imaging that was reported. An additional emdr was submitted to report the postoperative obstruction experienced by the patient. Should additional information be provided a supplemental emdr will be submitted.
 
Event Description
It was reported that the patient underwent a laparoscopic incisional hernia repair with ventralex st hernia patch on (b)(6) 2019. Post implant, the patient presented with a stricture in the small bowel which led to partial bowel obstruction, and underwent surgery. During the procedure, the surgeon encountered and removed dense like adhesions of the ventralex st to the bowel. Later, upon identifying a point of obstruction at the enterotomy site in the small bowel, the surgeon repaired the enterotomy and opened the stricture/obstruction. A small piece of bowel was sent to pathology; and the report stated metastatic poorly differentiated adenocarcinoma, possibly of pancreatic or cholangiocarcinoma. A work-up of the patient did not reveal any evidence of a primary tumor. A pet scan, however, ¿lit up¿ the entire mesh. The patient was referred to a surgical oncologist who considered removing the mesh. The implanting surgeon considered that pathology may be mistaking a ¿desmoplastic¿ response as cancer; the ¿desmoplastic¿ response being a reaction of the bowel to the mesh or the st coating. The surgeon also consulted a nuclear medicine physician who stated that most of the polypropylene products, including vascular grafts, light up on pet scans. The surgeon did not think that, the mesh by itself showing higher uptake of the tracer on the pet scan would be considered an ominous sign.
 
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Brand NameVENTRALEX ST
Type of DeviceSURGICAL 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 Key10394180
MDR Text Key202542416
Report Number1213643-2020-07301
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101928
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2021
Device Catalogue Number5950008
Device Lot NumberHUDP1035
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 Received08/11/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/02/2019
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: 08/11/2020 Patient Sequence Number: 1
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