VENTRALEX ST
Report
- Report Number
- 1213643-2018-00355
- Event Type
- Injury
- Date Received
- February 22, 2018
- Date of Event
- November 11, 2014
- Report Date
- August 1, 2024
- Manufacturer
- DAVOL INC., SUB. C.R. BARD, INC.
- Product Code
- FTL
- PMA / PMN Number
- K101928
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- 003
Narratives
CURRENTLY, IT IS UNKNOWN TO WHAT EXTENT THE VENTRALEX ST (DEVICE #1) MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INFORMATION PROVIDED ALLEGES MULTIPLE POST IMPLANT COMPLICATIONS. IT IS ALLEGED THAT ON (B)(6) 2014 THE PATIENT WAS DIAGNOSED "WITH UMBILICAL MESH-RELATED PAIN AND A DRAINING SINUS TRACT OF THE ABDOMINAL WALL THAT WAS LIKELY INFECTED" AND ON (B)(6) 2014 THE PATIENT UNDERWENT SURGERY TO "EXPLANT AN INFECTED UMBILICAL HERNIA MESH". THE DESCRIPTION DOES NOT CLEARLY DEFINE IF THE MESH EXPLANTED REFERS TO THE VENTRALEX ST (DEVICE #1), THE VENTRALEX ST (DEVICE #2), OR BOTH DEVICES. THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE AND NO MEDICAL RECORDS HAVE BEEN PROVIDED. INFLAMMATION IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE AS A POSSIBLE COMPLICATION. REGARDING INFECTION THE WARNING SECTION OF THE INSTRUCTIONS-FOR-USE STATES, ¿IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. THE PROSTHESIS MAY NOT HAVE TO BE REMOVED. AN UNRESOLVED INFECTION, HOWEVER, MAY REQUIRE REMOVAL OF THE PROSTHESIS.¿ ADDENDUM: H11: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED AND TO CORRECT MANUFACTURING DATE. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THERE IS NO CHANGE TO INITIAL DETERMINATION, NO CONCLUSIONS CAN BE MADE. PER MEDICAL RECORDS REVIEW, ABOUT 1 YEAR 6 MONTHS POST IMPLANT OF VENTRALEX ST, PATIENT WAS DIAGNOSED WITH INFECTION, INFLAMMATION, PAIN AND HERNIA RECURRENCE THEREBY UNDERWENT REPAIR WITH MESH REMOVAL.THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LISTS HERNIA RECURRENCE AS A POSSIBLE COMPLICATION. REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. UPDATED FIELDS: A2, A4, B4, B5, B7, D4 (UDI NO), E3, G1, G3, G6, H2, H6, H10, H11. CORRECTED FIELD: H4(MANUFACTURING DATE). THIS SUPPLEMENTAL EMDR REPRESENTS THE VENTRALEX ST (DEVICE #1). AN ADDITIONAL SUPPLEMENTAL EMDR WAS SUBMITTED TO REPRESENT THE VENTRALEX ST (DEVICE #2). 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: NOT RETURNED.
THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2013: THE PATIENT UNDERWENT A CT OF THE ABDOMEN DUE TO PAIN WHERE THREE SMALL, UNCOMPLICATED HERNIAS WERE OBSERVED WHERE NO BOWEL HAD HERNIATED, ONLY FAT. (B)(6) 2013: THE PATIENT UNDERWENT REPAIR OF AN INCARCERATED UMBILICAL HERNIA. A BARD/DAVOL VENTRALEX ST MESH PATCH 64.CM IN DIAMETER, REFERENCE NUMBER (B)(4), LOT NUMBER HUXC0717 (DEVICE #1) AND A BARD/DAVOL VENTRALEX ST MESH PATCH, 8.0CM IN DIAMETER, REFERENCE NUMBER (B)(4), LOT NUMBER HUXC0714 (DEVICE #2) WAS IMPLANTED DURING THIS REPAIR. (B)(6) 2013: THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF LOWER BACK PAIN THAT WAS RADIATING EVERYWHERE IN HIS BODY. AS REPORTED, THE PATIENT EXPRESSED DIFFICULTY WALKING AS WELL AS PAIN IN HIS HANDS AND NECK AND HAD BEEN TREATING THE PAIN WITH IBUPROFEN. AS REPORTED, LABS WERE DRAWN, AND THE PATIENT WAS PRESCRIBED OPIOID PAIN MEDICATIONS AND MUSCLE RELAXERS. (B)(6) 2013: THE PATIENT PRESENTED TO THE SAME EMERGENCY DEPARTMENT WITH COMPLAINTS OF THE SAME TYPE OF PAIN IN HIS UPPER BACK, BETWEEN HIS SHOULDER BLADES, AND RADIATING TOWARDS RIGHT SHOULDER. AS REPORTED, THE PATIENT WAS GIVEN PAIN MEDICATIONS AND INSTRUCTED TO RETURN TO THE EMERGENCY DEPARTMENT IMMEDIATELY IF HIS SYMPTOMS WORSEN IN ANY WAY. IT IS ALLEGED THAT THE PATIENT THEN BEGAN USING A CANE FOR MOBILITY. (B)(6) 2013: THE PATIENT PRESENTED TO THE HOSPITAL WITH SWELLING OF THE RIGHT SECOND DIGIT, THIRD LEFT DIGIT, UNABLE TO FULLY STRAIGHTEN HIS FINGERS, UNABLE TO FLEX INTO A FIST, AND HAD LIMITED SHOULDER RANGE OF MOTION DUE TO PAIN. AS REPORTED, THE DOCTOR NOTED THAT THE PATIENT WAS STILL EXPERIENCING PAIN SINCE HIS HERNIA REPAIR SURGERY AND DIAGNOSED THE PATIENT WITH CHRONIC PAIN OF UNKNOWN ETIOLOGY. IT IS ALLEGED THAT THE DIFFERENTIAL DIAGNOSIS FOR THE PATIENT'S PAIN INCLUDED FIBROMYALGIA OR A RHEUMATOID ETIOLOGY, SUCH AS ANKYLOSING SPONDYLITIS (AN INFLAMMATORY ARTHRITIS AFFECTING THE SPINE AND LARGE JOINTS). AS REPORTED, THE PATIENT WAS PRESCRIBED MELOXICAM (NONSTEROIDAL ANTI-INFLAMMATORY DRUG TO TREAT ARTHRITIS) AND HAD A COMPREHENSIVE LAB PANEL DRAWN. (B)(6) 2014: AS REPORTED, THE SITE OF THE PATIENT'S SEVERE UMBILICAL PAIN HAD BECOME REDDENED AND WAS PRODUCING AN NOXIOUS ODOR. IT IS ALLEGED THAT THE PATIENT WAS EXPERIENCING SEVERE DEPRESSION RELATED TO HIS DEBILITATING AND DETERIORATING CONDITION AND BEGAN TO CONTEMPLATE SUICIDE. (B)(6) 2014: THE PATIENT WAS DIAGNOSED WITH UMBILICAL MESH-RELATED PAIN AND A DRAINING SINUS TRACT OF THE ABDOMINAL WALL THAT WAS LIKELY INFECTED. (B)(6) 2014: THE PATIENT UNDERWENT SURGERY TO EXPLANT AN INFECTED UMBILICAL HERNIA MESH. AS REPORTED, DURING THE SURGERY, A SINUS TRACT AND "CONSIDERABLE EDEMA AND SIGNS OF INFLAMMATION" WERE OBSERVED AROUND AND NEAR THE ST BARD MESHES. IT IS ALLEGED THAT THE PATIENT'S OVERALL HEALTH IMPROVED FOLLOWING THE ST MESH REMOVAL AND HE WAS ABLE TO RESUME TOURING. AS REPORTED, THE PATIENT CONTINUES TO EXPERIENCE LIFE-ALTERING COMPLICATIONS FROM THE ORIGINAL ST BARD MESH, INCLUDING HAVING TO WEAR A WRAP WITH DUCT TAPE AROUND HIS ENTIRE MID-SECTION. AS ALLEGED, THE PATIENT HAS BEEN INJURED, SUSTAINED SEVERE AND PERMANENT PAIN, SUFFERING, ANXIETY, DEPRESSION, DISABILITY AND IMPAIRMENT DUE TO THE ALLEGED DEFECTIVE ST BARD MESH. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH FOUR VENTRAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST (DEVICE #1 & #2). PER OPERATIVE NOTES, ¿IDENTIFIED FOUR HERNIAS IN THE MIDLINE, TWO OF THEM WERE SMALL HERNIAS IDENTIFIED AT THE LEVEL OF UMBILICUS WERE REDUCED BACK INTO THE PERITONEAL SPACE. ANOTHER TWO INCARCERATED LARGER HERNIAS FOUND ABOVE THE UMBILICUS WERE PRIMARILY REPAIRED USING SUTURES. THEN, A VENTRALEX ST (DEVICE #1) PLACED IN THE MIDDLE HERNIA AND VENTRALEX ST (DEVICE #2) PLACED TO MOST SUPERIOR HERNIA AND SUTURED.¿ (B)(6) 2013 - PATIENT VISITED HOSPITAL FOR CHRONIC PAIN. (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH INFECTED UMBILICAL HERNIA MESH THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF VENTRALEX ST (DEVICE #1 & #2). PER OPERATIVE NOTES, ¿THE INFLAMMATORY HERNIA SAC PART OF SINUS TRACT WAS DISSECTED AND THE CONTENTS WERE REDUCED. THERE WAS CONSIDERABLE SIGNS OF EDEMA AND INFLAMMATION. THE VENTRALEX ST MESH (DEVICE #1) IDENTIFIED BY PALPATION IN THE MIDLINE FASCIA WAS DISSECTED. THEN, THE UNDERLYING VENTRALEX ST (DEVICE #2) WAS DISSECTED, LEAVING NO REMNANT OF THE MESH." ATTORNEY ALLEGES THAT THE PATIENT HAD ABSCESS, INFECTION, FISTULAE, CHRONIC PAIN AND HERNIA RECURRENCE. IT IS ALSO ALLEGED THAT THE PATIENT HAD LIFESTYLE CHANGES DUE TO MESH RELATED INJURIES AND EMOTIONAL INJURIES DUE TO SCARRING AND PAIN.
CURRENTLY, IT IS UNKNOWN TO WHAT EXTENT THE VENTRALEX ST (DEVICE #1) MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INFORMATION PROVIDED ALLEGES MULTIPLE POST IMPLANT COMPLICATIONS. IT IS ALLEGED THAT ON (B)(6) 2014 THE PATIENT WAS DIAGOSED "WITH UMBILICAL MESH-RELATED PAIN AND A DRAINING SINUS TRACT OF THE ABDOMINAL WALL THAT WAS LIKELY INFECTED" AND ON (B)(6) 2014 THE PATIENT UNDERWENT SURGERY TO "EXPLANT AN INFECTED UMBILICAL HERNIA MESH". THE DESCRIPTION DOES NOT CLEARLY DEFINE IF THE MESH EXPLANTED REFERS TO THE VENTRALEX ST (DEVICE #1), THE VENTRALEX ST (DEVICE #2), OR BOTH DEVICES. THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE AND NO MEDICAL RECORDS HAVE BEEN PROVIDED. INFLAMMATION IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE AS A POSSIBLE COMPLICATION. REGARDING INFECTION THE WARNING SECTION OF THE INSTRUCTIONS-FOR-USE STATES, ¿IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. THE PROSTHESIS MAY NOT HAVE TO BE REMOVED. AN UNRESOLVED INFECTION, HOWEVER, MAY REQUIRE REMOVAL OF THE PROSTHESIS.¿ SHOULD ADDITIONAL INFORMATION BE PROVIDED A SUPPLEMENTAL EMDR WILL BE SUBMITTED. THIS EMDR REPRESENTS THE BARD VENTRALEX ST (DEVICE#1). AN ADDITIONAL EMDR WAS SUBMITTED TO REPRESENT THE BARD VENTRALEX ST (DEVICE #2). THE INFORMATION PROVIDED BY BARD 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 BARD. NOT RETURNED.
THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2013: THE PATIENT UNDERWENT A CT OF THE ABDOMEN DUE TO PAIN WHERE THREE SMALL, UNCOMPLICATED HERNIAS WERE OBSERVED WHERE NO BOWEL HAD HERNIATED, ONLY FAT. ON (B)(6) 2013: THE PATIENT UNDERWENT REPAIR OF AN INCARCERATED UMBILICAL HERNIA. A BARD/DAVOL VENTRALEX ST MESH PATCH 64.CM IN DIAMETER, REFERENCE NUMBER 5950009, LOT NUMBER HUXC0717 (DEVICE #1) AND A BARD/DAVOL VENTRALEX ST MESH PATCH, 8.0CM IN DIAMETER, REFERENCE NUMBER 5950008, LOT NUMBER HUXC0714 (DEVICE #2) WAS IMPLANTED DURING THIS REPAIR. ON (B)(6) 2013: THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF LOWER BACK PAIN THAT WAS RADIATING EVERYWHERE IN HIS BODY. AS REPORTED, THE PATIENT EXPRESSED DIFFICULTY WALKING AS WELL AS PAIN IN HIS HANDS AND NECK AND HAD BEEN TREATING THE PAIN WITH IBUPROFEN. AS REPORTED, LABS WERE DRAWN, AND THE PATIENT WAS PRESCRIBED OPIOID PAIN MEDICATIONS AND MUSCLE RELAXERS. ON (B)(6) 2013: THE PATIENT PRESENTED TO THE SAME EMERGENCY DEPARTMENT WITH COMPLAINTS OF THE SAME TYPE OF PAIN IN HIS UPPER BACK, BETWEEN HIS SHOULDER BLADES, AND RADIATING TOWARDS RIGHT SHOULDER. AS REPORTED, THE PATIENT WAS GIVEN PAIN MEDICATIONS AND INSTRUCTED TO RETURN TO THE EMERGENCY DEPARTMENT IMMEDIATELY IF HIS SYMPTOMS WORSEN IN ANY WAY. IT IS ALLEGED THAT THE PATIENT THEN BEGAN USING A CANE FOR MOBILITY. ON (B)(6) 2013: THE PATIENT PRESENTED TO THE HOSPITAL WITH SWELLING OF THE RIGHT SECOND DIGIT, THIRD LEFT DIGIT, UNABLE TO FULLY STRAIGHTEN HIS FINGERS, UNABLE TO FLEX INTO A FIST, AND HAD LIMITED SHOULDER RANGE OF MOTION DUE TO PAIN. AS REPORTED, THE DOCTOR NOTED THAT THE PATIENT WAS STILL EXPERIENCING PAIN SINCE HIS HERNIA REPAIR SURGERY AND DIAGNOSED THE PATIENT WITH CHRONIC PAIN OF UNKNOWN ETIOLOGY. IT IS ALLEGED THAT THE DIFFERENTIAL DIAGNOSIS FOR THE PATIENT'S PAIN INCLUDED FIBROMYALGIA OR A RHEUMATOID ETIOLOGY, SUCH AS ANKYLOSING SPONDYLITIS (AN INFLAMMATORY ARTHRITIS AFFECTING THE SPINE AND LARGE JOINTS). AS REPORTED, THE PATIENT WAS PRESCRIBED MELOXICAM (NONSTEROIDAL ANTI-INFLAMMATORY DRUG TO TREAT ARTHRITIS) AND HAD A COMPREHENSIVE LAB PANEL DRAWN. ON (B)(6) 2014: AS REPORTED, THE SITE OF THE PATIENT'S SEVERE UMBILICAL PAIN HAD BECOME REDDENED AND WAS PRODUCING AN NOXIOUS ODOR. IT IS ALLEGED THAT THE PATIENT WAS EXPERIENCING SEVERE DEPRESSION RELATED TO HIS DEBILITATING AND DETERIORATING CONDITION, AND BEGAN TO CONTEMPLATE SUICIDE. ON (B)(6) 2014: THE PATIENT WAS DIAGNOSED WITH UMBILICAL MESH-RELATED PAIN AND A DRAINING SINUS TRACT OF THE ABDOMINAL WALL THAT WAS LIKELY INFECTED. ON (B)(6) 2014: THE PATIENT UNDERWENT SURGERY TO EXPLANT AN INFECTED UMBILICAL HERNIA MESH. AS REPORTED, DURING THE SURGERY, A SINUS TRACT AND "CONSIDERABLE EDEMA AND SIGNS OF INFLAMMATION" WERE OBSERVED AROUND AND NEAR THE ST BARD MESHES. IT IS ALLEGED THAT THE PATIENT'S OVERALL HEALTH IMPROVED FOLLOWING THE ST MESH REMOVAL AND HE WAS ABLE TO RESUME TOURING. AS REPORTED, THE PATIENT CONTINUES TO EXPERIENCE LIFE-ALTERING COMPLICATIONS FROM THE ORIGINAL ST BARD MESH, INCLUDING HAVING TO WEAR A WRAP WITH DUCT TAPE AROUND HIS ENTIRE MID-SECTION. AS ALLEGED, THE PATIENT HAS BEEN INJURED, SUSTAINED SEVERE AND PERMANENT PAIN, SUFFERING, ANXIETY, DEPRESSION, DISABILITY AND IMPAIRMENT DUE TO THE ALLEGED DEFECTIVE ST BARD MESH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 132834 | VENTRALEX ST | SURGICAL MESH | FTL | DAVOL INC., SUB. C.R. BARD, INC. | NA | HUXC0717 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Male | Hospitalization| S| R |