MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 MESH ¿ VENTRALEX; SURGICAL MESH

Catalog Number UNKAA077

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Hematoma (1884); Seroma (2069); Hernia (2240)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

Based on the information available at this time, no conclusions can be made.The information obtained is limited to the article.Additional information has been requested.There is no discussion within the article, or indication of the device being directly or indirectly related to any reported patient outcome.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Hernia recurrence, seroma and hematoma are known inherent risks of surgery and are listed in the adverse reactions section of the instructions-for-use supplied with the device as possible complications.Note, the date of event is provided as an estimate ((b)(6) 2015) based on the information provided.This mdr represents the ventralex mesh.An additional mdr was submitted to represent the ventralex st mesh.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 Description

Per journal article: "ventralex st patch for laparoscopic repair of ventral hernias" this article is a study of 93 patients who had a ventral primary nonobstructive abdominal wall defects (up to 3 cm) treated laparoscopically using the intraperitoneal onlay mesh repair (ipom) technique with either a ventralex mesh (22 patients) or a ventralex st patch (71 patients) performed by a single surgeon, between 01-jan-2015 to 31-jan-2020.Postoperative complications were recorded in 15 cases (mesh group not specified): 6 cases with seroma (necessitating evacuation in 2 cases, while the other were treated conservatively), 9 cases with superficial hematoma (treated conservatively).There were no late postoperative complications and at the 90 day visit, no patient referred any pain or discomfort related to the procedure.Prior to the median follow-up time (20-81 months) 25 patients dropped out of the study, resulting in the long-term study assessment being limited to 9 patients in the ventralex group and 59 patients in the ventralex st group.Of those remaining in the study 1 patient developed a recurrence (ventralex group).The article reports ¿other complaints were recorded¿ in 1 patient from the ventralex group and 2 patients from the ventralex st group, however the nature of these complaints where not reported.The author noted in the article that it was ¿significantly more difficult to maneuver¿ the ventralex mesh during laparoscopic surgery when compared to ventralex st, often resulting in suboptimal placement of the ventralex mesh.In conclusion the authors noted ¿the use of ventralex st patch for laparoscopic intraperitoneal onlay mesh repair of small and medium size ventral hernia is simpler and more cost-effective than standard laparoscopic patches, with superior results when compared to ventralex patch.¿ note, this report represents the ventralex mesh used.

• Brand Name: MESH ¿ VENTRALEX
• Type of Device: SURGICAL 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 Key: 18021195
• MDR Text Key: 326724969
• Report Number: 1213643-2023-00394
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: RO
• PMA/PMN Number: K132441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2023
• 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): Required Intervention