G2 EXPRESS FILTER SYSTEM - FEMORAL
Report
- Report Number
- 2020394-2014-00289
- Event Type
- Injury
- Date Received
- June 27, 2014
- Date of Event
- December 10, 2012
- Report Date
- June 3, 2014
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DTK
- PMA / PMN Number
- K080668
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- ATTORNEY
Narratives
THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE DEVICE WAS NOT RETURNED. IMAGES WERE NOT PROVIDED. THE COMPLAINT INVESTIGATION IS INCONCLUSIVE FOR FILTER LIMB DETACHMENT, LIMB PERFORATION AND DIFFICULT TO REMOVE. THE ROOT CAUSE WAS UNABLE TO DETERMINE BASED ON THE AVAILABLE INFORMATION.
MANUFACTURING REVIEW: A MANUFACTURING REVIEW COULD NOT BE CONDUCTED AS THE LOT NUMBER WAS NOT PROVIDED. VISUAL/MICROSCOPIC INSPECTION: AS THE DEVICE WAS NOT RETURNED, AN INSPECTION COULD NOT BE PERFORMED. FUNCTIONAL/PERFORMANCE EVALUATION: AS THE DEVICE WAS NOT RETURNED, AN EVALUATION COULD NOT BE PERFORMED. MEDICAL RECORDS REVIEW: PATIENT WAS INVOLVED IN A MVC AND SUSTAINED MULTIPLE INJURIES. AN INFERIOR VENA CAVA FILTER WAS INDICATED AS PATIENT WAS HIGH RISK FOR THROMBUS AND THROMBOEMBOLUS. THE FILTER WAS SUCCESSFULLY DEPLOYED IN THE INFRARENAL IVC WITHOUT COMPLICATION, AND PATIENT WAS HEMODYNAMICALLY STABLE AT THE CONCLUSION OF THE PROCEDURE. APPROXIMATELY FOUR YEARS POST FILTER DEPLOYMENT, DURING A FILTER RETRIEVAL PROCEDURE, SCOUT FLUOROSCOPIC IMAGES IDENTIFIED A DETACHED LIMB IN THE IVC. THE RIGHT INTERNAL JUGULAR VEIN WAS ACCESSED AND A VENACAVAOGRAM DEMONSTRATED INTRAMURAL INCORPORATION OF THE FILTER HOOK INTO THE IVC WALL. MULTIPLE ATTEMPTS TO ENGAGE THE FILTER APEX WERE UNSUCCESSFUL; THEREFORE, AN 8MM X 4CM BALLOON WAS DEPLOYED ADJACENT TO THE FILTER APEX AND A GUIDEWIRE WAS USED TO TRY AND FREE THE FILTER APEX FROM THE IVC WALL AND LOOP A LARGE BAND OF SCAR TISSUE. AN ATTEMPT TO PULL THROUGH THE SCAR TISSUE RESULTED IN THE PATIENT EXPERIENCING ABDOMINAL PAIN; THEREFORE, THIS APPROACH WAS STOPPED. NEXT, A 4MM X 4CM BALLOON WAS USED TO TRY AND BREAK THROUGH THE SCAR TISSUE; HOWEVER, THIS APPROACH WAS UNSUCCESSFUL AND THE PROCEDURE WAS CONCLUDED. PATIENT TOLERATED THE PROCEDURE WELL WITHOUT COMPLICATIONS. A FOLLOW UP CT SCAN WAS PERFORMED AND DEMONSTRATED A DETACHED FILTER LIMB IN THE RIGHT PSOAS MUSCLE; SEVERAL LIMBS EXTENDING OUTSIDE THE IVC WALL; AND ONE LIMB EXTENDING INTO THE AORTA WITH A SMALL AMOUNT OF INTIMAL THICKENING BELOW IT. ELEVEN DAYS LATER, THE PATIENT UNDERWENT AN OPEN SURGICAL FILTER RETRIEVAL PROCEDURE. THE PATIENT¿S ABDOMEN WAS PREPPED AND UPPER MIDLINE SCAR WAS EXCISED. A FILTER LIMB WAS IDENTIFIED WITHIN THE SECOND PORTION OF THE DUODENUM, AND THE FILTER WAS DISSECTED AROUND THIS LIMB. THE FILTER WAS EASILY PALPABLE WITHIN THE IVC AND MULTIPLE LIMBS EXTENDING THROUGH THE ANTERIOR WALL OF THE IVC WERE IDENTIFIED. THERE WAS SOME HEMATOMA ADJACENT TO THE IVC WHERE A FILTER LIMB ENTERED THE AORTA; HOWEVER, NO ACTIVE EXTRAVASATION OF ENTERIC CONTENTS FROM THE DUODENUM OR BLOOD FROM THE AORTA WAS IDENTIFIED. THE DETACHED LIMB IN THE DUODENUM WAS TRANSECTED AND REMOVED AND THE DUODENUM WAS REPAIRED. THE FILTER LIMB ENTERING THE AORTA WAS TRANSECTED AND REMOVED AND THE AORTA WAS REPAIRED. THE IVC WAS OPENED LONGITUDINALLY AND THERE WAS A LARGE AMOUNT OF FIBROUS TISSUE ADHERING TO THE WALL. THE FIBROUS TISSUE WAS LYSED AND A LARGE THROMBUS WAS REMOVED FROM WITHIN THE FILTER. THE FILTER AND REMAINING FIBROUS TISSUE FROM THE INNER LINING OF THE VENA CAVA WAS REMOVED. PATIENT WAS HEMODYNAMICALLY STABLE AT THE CONCLUSION OF THE PROCEDURE, AND DISCHARGED HOME ON POSTOPERATIVE DAY FOUR. IMAGE/PHOTO REVIEW: NO MEDICAL IMAGES HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER. CONCLUSION: THE MEDICAL RECORDS ALLEGE THAT SCOUT IMAGING PRIOR TO RETRIEVAL ALLEGEDLY DEMONSTRATED A DETACHED LIMB. A VENACAVOGRAM ALLEGEDLY SHOWED INTRAMURAL INCORPORATION OF THE HOOK INTO THE IVC WALL. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE ALLEGEDLY MADE TO ENGAGE THE FILTER APEX. SEVERAL TECHNIQUES WERE ALLEGEDLY PERFORMED IN AN ATTEMPT TO REPOSITION THE FILTER APEX UNSUCCESSFULLY. THE PROCEDURE WAS ABORTED. A CT SCAN AFTER THE PROCEDURE ALLEGEDLY DEMONSTRATED MULTIPLE LIMBS EXTENDING OUTSIDE OF THE IVC WITH ONE DETACHED LIMB THAT APPEARS TO BE WITHIN THE RIGHT PSOAS MUSCLE. ANOTHER LIMB ALLEGEDLY EXTENDED INTO THE AORTA. OPEN SURGERY WAS ALLEGEDLY PERFORMED IN ORDER TO REMOVE THE FILTER. ONE LIMB REPORTEDLY PERFORATED THE AORTA AND ANOTHER EXTENDED INTO THE DUODENUM. ALLEGEDLY, THE FILTER WAS SUCCESSFULLY REMOVED AND DUODENUM AND AORTA WERE REPAIRED. BASED ON THE MEDICAL RECORD REVIEW, LIMB DETACHMENT, FILTER TILT, PERFORATION OF THE IVC, AND AN UNSUCCESSFUL RETRIEVAL ATTEMPT CAN BE CONFIRMED. UNABLE TO DETERMINE THE ROOT CAUSE BASED UPON THE AVAILABLE INFORMATION. LABELING REVIEW: THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: WARNINGS: MOVEMENT, MIGRATION OR TILT OF THE FILTER ARE KNOWN COMPLICATIONS OF VENA CAVA FILTERS. POTENTIAL COMPLICATIONS: FILTER MALPOSITION - FILTER TILT. (B)(4). 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.
TO ENSURE COMPLIANCE TO 21 CFR 803.50 A RETROSPECTIVE REVIEW OF THIS FILE WAS CONDUCTED TO DETERMINE IF GOOD FAITH EFFORTS WERE MADE TO OBTAIN THE REQUIRED INFORMATION AND/OR AN EXPLANATION OF WHY ANY REQUIRED INFORMATION WAS NOT PROVIDED. A FOLLOW UP ATTEMPT WAS MADE WITH OUTSIDE COUNSEL TO OBTAIN ANY INFORMATION PERTAINING TO THE PATIENT, PRODUCT, AND/OR PROCEDURAL DETAILS (E.G. DATE OF THE EVENT, RELEVANT TEST DATA, RELEVANT HISTORY, LOT #, CATALOG #, IMPLANT AND/OR EXPLANTED DATES, AND CONCOMITANT PRODUCT(S) OR THERAPY) THAT WERE NOT PREVIOUSLY OBTAINED DURING THE INITIAL INVESTIGATION. THE OUTSIDE COUNSEL WAS ABLE TO PROVIDE NEW PATIENT INFORMATION, DATE OF EVENT, RELEVANT TEST DATA, AND OTHER RELEVANT HISTORY, WHICH WAS UPDATED IN THE APPROPRIATE SECTIONS. HOWEVER, BECAUSE THIS EVENT IS CURRENTLY THE SUBJECT OF LITIGATION, WE ALSO REVIEWED MATERIALS OBTAINED THROUGH THE LITIGATION PROCESS IN AN EFFORT TO PROVIDE THE ADDITIONAL DETAILS BEING SOUGHT, AND INCORPORATED THE RELEVANT INFORMATION DISCLOSED IN THOSE MATERIALS WHEREVER AVAILABLE.
NEW INFORMATION RECEIVED: IT WAS REPORTED THAT A VENA CAVA FILTER WAS SUCCESSFULLY DEPLOYED PROPHYLACTICALLY POST TRAUMA. APPROXIMATELY FOUR YEARS POST FILTER DEPLOYMENT, DURING A FILTER RETRIEVAL PROCEDURE, GUIDED FLUOROSCOPY DEMONSTRATED THE FILTER APEX EMBEDDED IN THE IVC WALL AND A DETACHED LIMB IN THE IVC. DESPITE MULTIPLE ATTEMPTS MADE WITH MULTIPLE DEVICES, THE FILTER COULD NOT BE RETRIEVED. THE PATIENT WAS HEMODYNAMICALLY STABLE AT THE CONCLUSION OF THE PROCEDURE. A FOLLOW-UP CT SCAN DEMONSTRATED SEVERAL FILTER LIMBS EXTENDING OUTSIDE THE IVC WALL WITH ONE LIMB EXTENDING INTO THE AORTA AND THE DETACHED LIMB WITHIN THE RIGHT PSOAS MUSCLE. ELEVEN DAYS POST FILTER RETRIEVAL ATTEMPT MADE, AN OPEN CUT DOWN PROCEDURE WAS PERFORMED TO REMOVE THE FILTER AND DETACHED LIMB. THE DETACHED FILTER LIMB WAS IDENTIFIED IN THE DUODENUM. THERE WAS NO ACTIVE EXTRAVASATION FROM THE DUODENUM OR AORTA IDENTIFIED. THE PATIENT WAS HEMODYNAMICALLY STABLE AT THE CONCLUSION OF THE PROCEDURE.
IT WAS REPORTED THAT APPROXIMATELY THREE YEARS AFTER IMPLANTATION OF A VENA CAVA FILTER, IMAGING DEMONSTRATED SOME DETACHED FILTER LIMBS, AS WELL AS PERFORATION OF THE IVC AND AORTA. AN ATTEMPT WAS MADE TO REMOVE THE FILTER, HOWEVER, IT WAS UNSUCCESSFUL. ALLEGEDLY, OPEN SURGERY WAS PERFORMED; HOWEVER, IT IS UNKNOWN IF THE FILTER OR ANY OF THE DETACHED FILTER LIMBS WERE REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 376269 | G2 EXPRESS FILTER SYSTEM - FEMORAL | VENA CAVA FILTER | DTK | BARD PERIPHERAL VASCULAR, INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Hospitalization| R |