VENTRALIGHT ST MESH

Report

Report Number: 1213643-2025-01215
Event Type: Injury
Date Received: December 16, 2025
Date of Event: March 1, 2016
Report Date: December 8, 2025
Manufacturer: DAVOL INC., SUB. C.R. BARD, INC. -1213643
Product Code: FTL
PMA / PMN Number: K101851
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: EG
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

BASED ON THE ARTICLE, NO DEFINITIVE CONCLUSIONS CAN BE DRAWN. THE INFORMATION IS LIMITED TO WHAT IS REPORTED IN THE ARTICLE. THE ARTICLE DOES NOT REPORT ANY SPECIFIC DEVICE MALFUNCTION OR INDICATE THAT POST-OPERATIVE COMPLICATIONS WERE CAUSED OR CONTRIBUTED TO BY THE VENTRALIGHT ST MESH. THEREFORE, NO CONNECTION CAN BE ESTABLISHED BETWEEN THE IMPLANT AND ANY PATIENT ADVERSE OUTCOME. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. INFECTION IS A CLINICALLY UNDERSTOOD POTENTIAL COMPLICATIONS OF SURGERY/USE OF THE DEVICE AND IS IDENTIFIED IN THE INSTRUCTIONS-FOR-USE PROVIDED WITH THE DEVICE, AS A POSSIBLE COMPLICATION. REGARDING INFECTION, THE WARNINGS SECTION STATES THAT "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 MESH." NOTE, THE DATE OF EVENT (01-MAR-2016) IS CONSIDERED TO BE A BEST ESTIMATE. 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.

Description of Event or Problem · 0

PER JOURNAL ARTICLE: "FRAILTY PREDICTS RECURRENCE AFTER LAPAROSCOPIC NISSEN FUNDOPLICATION WITH MESH CRUROPLASTY FOR GIANT SLIDING HIATAL HERNIA WITH SEVERE REFLUX ESOPHAGITIS IN ELDERLY PATIENTS: A MULTICENTER RETROSPECTIVE STUDY." THIS RETROSPECTIVE MULTICENTER STUDY INCLUDED 266 PATIENTS (71 MALES AND 195 FEMALES) WHO UNDERWENT MESH CRUROPLASTY AND LAPAROSCOPIC NISSEN FUNDOPLICATION (LNF) FOR GIANT SLIDING HIATAL HERNIA (>5 CM) WITH SEVERE REFLUX ESOPHAGITIS (DEMEESTER SCORE >100) BETWEEN MARCH 2016 AND MARCH 2022. THE PATIENTS WERE DIVIDED INTO TWO GROUPS: NON-RECURRENCE (N = 241) AND RECURRENCE (N = 25). OF THESE, 241 PATIENTS MAINTAINED A SUCCESSFUL REPAIR, WHILE 25 DEVELOPED RECURRENT HIATAL HERNIA. THE OVERALL RECURRENCE RATE WAS 9.4%. THE SUBJECT PATIENTS HAD LAPAROSCOPIC REDUCTION OF THE HERNIA, POSTERIOR CRUROPLASTY WITH NON-ABSORBABLE SUTURES, AND REINFORCEMENT USING A U-SHAPED FENESTRATED VENTRALIGHT ST COMPOSITE MESH. THE MESH WAS SECURED WITH POLYPROPYLENE SUTURES OR TITANIUM TACKERS. THE MEAN POSTOPERATIVE HOSPITAL STAY WAS SIGNIFICANTLY LONGER IN THE RECURRENCE GROUP. POSTOPERATIVE COMPLICATIONS OCCURRED IN 34 PATIENTS, WITH HIGHER RATES IN THE RECURRENCE GROUP (12% VS. 3.6% READMISSION WITHIN 30 DAYS). REPORTED COMPLICATIONS INCLUDED SUPERFICIAL SURGICAL SITE INFECTIONS (N=2), ORGAN/SPACE INFECTIONS (N=2), ILEUS (N=1), INTRA-ABDOMINAL COLLECTION (N=2), AND 30-DAY MORTALITY IN 7 PATIENTS, PRIMARILY DUE TO SEPTIC SHOCK (N=2) AND CARDIORESPIRATORY FAILURE (N=5). REOPERATION WAS REQUIRED IN 12 RECURRENT CASES. THE ARTICLE CONCLUDES THAT FRAILTY IS AN INDEPENDENT PREDICTOR OF HIATAL HERNIA RECURRENCE. INTEGRATING FRAILTY ASSESSMENT INTO PREOPERATIVE WORKFLOWS COULD OPTIMIZE PATIENT SELECTION AND IMPROVE SURGICAL OUTCOMES. NOTE: THERE IS NO INFORMATION PROVIDED IN THE ARTICLE INDICATING THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE POSTOPERATIVE PATIENT COMPLICATION(S). HOWEVER, AS POSTOPERATIVE COMPLICATIONS DID PRESENT AND MAY REQUIRE MEDICAL/SURGICAL INTERVENTION WE ARE REPORTING THIS AS A SERIOUS INJURY MDR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2205811	VENTRALIGHT ST MESH	SURGICAL MESH	FTL	DAVOL INC., SUB. C.R. BARD, INC. -1213643	NA	NI

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Required Intervention