MERIDIAN FILTER SYSTEM - JUGULAR
Report
- Report Number
- 2020394-2017-01721
- Event Type
- Death
- Date Received
- December 8, 2017
- Report Date
- April 12, 2022
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DTK
- PMA / PMN Number
- K102511
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- 003
Narratives
H10: MANUFACTURING REVIEW: A LOT HISTORY REVIEW WAS PERFORMED. THIS IS THE ONLY COMPLAINT TO DATE FOR THIS LOT NUMBER. THEREFORE, A DEVICE HISTORY RECORD REVIEW IS NOT REQUIRED. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED. THERE WAS NO SPECIFIC DEFICIENCY ALLEGED IN THE PROVIDED MEDICAL RECORDS. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE AS NO OBJECTIVE EVIDENCE HAS BEEN PROVIDED TO CONFIRM ANY ALLEGED DEFICIENCY WITH THE FILTER. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTS (E.G. PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, AND UNIT LABEL) SHOWED THAT THE PRODUCT LABELING IS ADEQUATE. H11: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.
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT AFTER BEING DIAGNOSED WITH DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM. THE DEVICE HAS NOT BEEN REMOVED AND IT IS UNKNOWN IF THERE WERE ANY ATTEMPTS MADE TO RETRIEVE THE FILTER. THE PATIENT WAS ALLEGEDLY DIAGNOSED WITH LARGE RIGHT PULMONARY EMBOLUS AND DEEP VEIN THROMBI AND SUBSEQUENTLY EXPIRED.
NO HOSPITAL/MEDICAL RECORDS OR MEDICAL IMAGES HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER. AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WILL NOT BE PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. 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.
MANUFACTURING REVIEW: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A MANUFACTURING REVIEW COULD NOT BE PERFORMED. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. IMAGES AND MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE AS NO OBJECTIVE EVIDENCE HAS BEEN PROVIDED TO CONFIRM ANY ALLEGED DEFICIENCY WITH THE FILTER. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. LABELING REVIEW: THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: POTENTIAL COMPLICATIONS: POSSIBLE COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: MOVEMENT, MIGRATION OR TILT OF THE FILTER ARE KNOWN COMPLICATIONS OF VENA CAVA FILTERS. MIGRATION OF FILTERS TO THE HEART OR LUNGS HAS BEEN REPORTED. THERE HAVE ALSO BEEN REPORTS OF CAUDAL MIGRATION OF THE FILTER. MIGRATION MAY BE CAUSED BY PLACEMENT IN IVCS WITH DIAMETERS EXCEEDING THE APPROPRIATE LABELED DIMENSIONS SPECIFIED IN THIS IFU. MIGRATION MAY ALSO BE CAUSED BY IMPROPER DEPLOYMENT, DEPLOYMENT INTO CLOTS AND/OR DISLODGEMENT DUE TO LARGE CLOT BURDENS. FILTER FRACTURES ARE A KNOWN COMPLICATION OF VENA CAVA FILTERS. THERE HAVE BEEN SOME REPORTS OF SERIOUS PULMONARY AND CARDIAC COMPLICATIONS WITH VENA CAVA FILTERS REQUIRING THE RETRIEVAL OF THE FRAGMENT UTILIZING ENDOVASCULAR AND/OR SURGICAL TECHNIQUES. DETACHMENT OF COMPONENTS PERFORATION OR OTHER ACUTE OR CHRONIC DAMAGE OF THE IVC WALL. ACUTE OR RECURRENT PULMONARY EMBOLISM. THIS HAS BEEN REPORTED DESPITE FILTER USAGE. IT IS NOT KNOWN IF THROMBI PASSED THROUGH THE FILTER, OR ORIGINATED FROM SUPERIOR OR COLLATERAL VESSELS. DEEP VEIN THROMBOSIS. CAVAL THROMBOSIS/OCCLUSION EXTRAVASATION OF CONTRAST MATERIAL AT TIME OF VENACAVOGRAM AIR EMBOLISM HEMATOMA OR NERVE INJURY AT THE PUNCTURE SITE OR SUBSEQUENT RETRIEVAL SITE HEMORRHAGE RESTRICTION OF BLOOD FLOW OCCLUSION OF SMALL VESSELS DISTAL EMBOLIZATION INFECTION INTIMAL TEAR STENOSIS AT IMPLANT SITE FAILURE OF FILTER EXPANSION/INCOMPLETE EXPANSION INSERTION SITE THROMBOSIS FILTER MALPOSITION VESSEL INJURY ARTERIOVENOUS FISTULA BACK OR ABDOMINAL PAIN FILTER TILT HEMOTHORAX ORGAN INJURY PHLEGMASIA CERULEA DOLENS PNEUMOTHORAX POSTPHLEBITIC SYNDROME STROKE THROMBOPHLEBITIS VENOUS ULCERATION BLOOD LOSS GUIDEWIRE ENTRAPMENT PAIN ALL OF THE ABOVE COMPLICATIONS MAY BE ASSOCIATED WITH SERIOUS ADVERSE EVENTS SUCH AS MEDICAL INTERVENTION AND/OR DEATH. 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.
MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, SUBASSEMBLIES, MANUFACTURING PROCESS AND QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY EVENT REPORTED TO DATE FOR THIS LOT NUMBER AND FAILURE MODE. MEDICAL RECORD REVIEW: PATIENT WITH RECURRENT GI BLEEDS AND CONTRAINDICATED FOR ANTICOAGULATION HAD A VENA CAVA FILTER PLACED INFRARENAL. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. IMAGES WERE NOT PROVIDED FOR REVIEW. MEDICAL RECORDS WERE PROVIDED AND REVIEWED. THERE WAS NO SPECIFIC DEFICIENCY ALLEGED IN THE PROVIDED MEDICAL RECORDS. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE AS NO OBJECTIVE EVIDENCE HAS BEEN PROVIDED TO CONFIRM ANY ALLEGED DEFICIENCY WITH THE FILTER. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. LABELING REVIEW: THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: POTENTIAL COMPLICATIONS: POSSIBLE COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: - MOVEMENT, MIGRATION OR TILT OF THE FILTER ARE KNOWN COMPLICATIONS OF VENA CAVA FILTERS. MIGRATION OF FILTERS TO THE HEART OR LUNGS HAS BEEN REPORTED. THERE HAVE ALSO BEEN REPORTS OF CAUDAL MIGRATION OF THE FILTER. MIGRATION MAY BE CAUSED BY PLACEMENT IN IVCS WITH DIAMETERS EXCEEDING THE APPROPRIATE LABELED DIMENSIONS SPECIFIED IN THIS IFU. MIGRATION MAY ALSO BE CAUSED BY IMPROPER DEPLOYMENT, DEPLOYMENT INTO CLOTS AND/OR DISLODGEMENT DUE TO LARGE CLOT BURDENS. - FILTER FRACTURES ARE A KNOWN COMPLICATION OF VENA CAVA FILTERS. THERE HAVE BEEN SOME REPORTS OF SERIOUS PULMONARY AND CARDIAC COMPLICATIONS WITH VENA CAVA FILTERS REQUIRING THE RETRIEVAL OF THE FRAGMENT UTILIZING ENDOVASCULAR AND/OR SURGICAL TECHNIQUES. - DETACHMENT OF COMPONENTS - PERFORATION OR OTHER ACUTE OR CHRONIC DAMAGE OF THE IVC WALL. - ACUTE OR RECURRENT PULMONARY EMBOLISM. THIS HAS BEEN REPORTED DESPITE FILTER USAGE. IT IS NOT KNOWN IF THROMBI PASSED THROUGH THE FILTER, OR ORIGINATED FROM SUPERIOR OR COLLATERAL VESSELS. - DEEP VEIN THROMBOSIS - CAVAL THROMBOSIS/OCCLUSION - EXTRAVASATION OF CONTRAST MATERIAL AT TIME OF VENACAVOGRAM - AIR EMBOLISM - HEMATOMA OR NERVE INJURY AT THE PUNCTURE SITE OR SUBSEQUENT RETRIEVAL SITE - HEMORRHAGE - RESTRICTION OF BLOOD FLOW - OCCLUSION OF SMALL VESSELS - DISTAL EMBOLIZATION - INFECTION - INTIMAL TEAR - STENOSIS AT IMPLANT SITE - FAILURE OF FILTER EXPANSION/INCOMPLETE EXPANSION - INSERTION SITE THROMBOSIS - FILTER MALPOSITION - VESSEL INJURY - ARTERIOVENOUS FISTULA - BACK OR ABDOMINAL PAIN - FILTER TILT - HEMOTHORAX - ORGAN INJURY - PHLEGMASIA CERULEA DOLENS - PNEUMOTHORAX - POSTPHLEBITIC SYNDROME - STROKE - THROMBOPHLEBITIS - VENOUS ULCERATION - BLOOD LOSS - GUIDEWIRE ENTRAPMENT - PAIN ALL OF THE ABOVE COMPLICATIONS MAY BE ASSOCIATED WITH SERIOUS ADVERSE EVENTS SUCH AS MEDICAL INTERVENTION AND/OR DEATH. 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.
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOME TIME POST VENA CAVA FILTER DEPLOYMENT (DATE NOT PROVIDED) THE PATIENT EXPIRED. THERE WAS NO SPECIFIC DEVICE MALFUNCTION REPORTED THAT MAY OR MAY NOT HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S DEATH. THE CAUSE OF THE PATIENT¿S DEATH WAS NOT PROVIDED. NO OTHER PERTINENT PATIENT, DEVICE OR MEDICAL INFORMATION WAS PROVIDED LEADING UP TO OR SURROUNDING THE EVENT.
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOME TIME POST VENA CAVA FILTER DEPLOYMENT (DATE NOT PROVIDED) THE PATIENT EXPIRED. THERE WAS NO SPECIFIC DEVICE MALFUNCTION REPORTED THAT MAY OR MAY NOT HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S DEATH, THE CAUSE OF THE PATIENT¿S DEATH WAS NOT PROVIDED. NO OTHER PERTINENT PATIENT, DEVICE OR MEDICAL INFORMATION WAS PROVIDED LEADING UP TO OR SURROUNDING THE EVENT.
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOME TIME POST VENA CAVA FILTER DEPLOYMENT (DATE NOT PROVIDED) THE PATIENT EXPIRED. THERE WAS NO SPECIFIC DEVICE MALFUNCTION REPORTED THAT MAY OR MAY NOT HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S DEATH, THE CAUSE OF THE PATIENT¿S DEATH WAS NOT PROVIDED. NO OTHER PERTINENT PATIENT, DEVICE OR MEDICAL INFORMATION WAS PROVIDED LEADING UP TO OR SURROUNDING THE EVENT. NEW INFORMATION: IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT AFTER BEING DIAGNOSED WITH DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM. THE DEVICE HAS NOT BEEN REMOVED AND IT IS UNKNOWN IF THERE WERE ANY ATTEMPTS MADE TO RETRIEVE THE FILTER. THE PATIENT ALLEGEDLY EXPERIENCED LARGE RIGHT PULMONARY EMBOLUS AND DEEP VEIN THROMBI AND SUBSEQUENTLY EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 881002 | MERIDIAN FILTER SYSTEM - JUGULAR | VENA CAVA FILTER | DTK | BARD PERIPHERAL VASCULAR, INC. | GFWE3421 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Life Threatening| D |