DENALI JUGULAR SYSTEM
Report
- Report Number
- 2020394-2019-03471
- Event Type
- Death
- Date Received
- September 25, 2019
- Date of Event
- January 25, 2018
- Report Date
- February 24, 2022
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DTK
- UDI-DI
- 00801741040795
- PMA / PMN Number
- K130366
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
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. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED. THERE WERE NO DEVICE DEFICIENCIES IDENTIFIED WITHIN THE MEDICAL RECORDS. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE ALLEGED FILTER TILT AND FILTER MIGRATION 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. (EXPIRY DATE: 12/2016).
H10: 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. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED. APPROXIMATELY, THREE YEARS AND EIGHT MONTHS OF POST DEPLOYMENT, ON A COMPUTED TOMOGRAPHY OF ABDOMEN AND PELVIS WAS PERFORMED FOR HEMATURIA. THE STUDY SHOWED THAT AN INFERIOR VENA CAVA FILTER WITH TIP APEX AT THE LEVEL OF THE PORTA AND INTRAVENOUS INTO THE MEDIAL LIVER. THE INFERIOR VENA CAVA FILTER WAS IN A MORE SUPERIOR LOCATION THAN CUSTOMARY, APEX AT THE ENTRANCE TO THE LIVER. AROUND, THREE MONTHS AND ONE WEEK LATER, AN X-RAY OF ABDOMEN WAS PERFORMED FOR ABDOMINAL PAIN. THE STUDY SHOWED AN INFERIOR VENA CAVA FILTER REMAINED IN PLACE. AROUND, SIX MONTHS AND ONE WEEK LATER, DURING LEFT HEART CATHETERIZATION PROCEDURE, A FLUOROSCOPIC EVALUATION WAS PERFORMED. THE STUDY SHOWED EVIDENCE OF A HOOK INFERIOR VENA CAVA FILTER WHICH APPEARED TO BE IN A POSITION SUPERIOR TO THE RENAL VEINS. IT WAS CONCLUDED WITH THE PRESENCE OF VERY HIGH INFERIOR VENA CAVA FILTER. HOWEVER, IT WAS RECOMMENDED STRONG CONSIDERATION OF REMOVAL, GIVEN LACK OF CLINICAL UTILITY AT THIS POINT. AROUND, SEVEN MONTHS AND TWO WEEKS LATER, DURING CONSULTATION, IT WAS FOUND THAT THE INFERIOR VENA CAVA FILTER AT END OF THERAPEUTIC UTILITY IN POOR POSITION AND REMOVAL WAS RECOMMENDED. HOWEVER, THE FLUOROSCOPY SHOWED THAT IT WAS ABOVE THE RENAL VEINS, AND IT HAS A FAIRLY GOOD POSITION AND TOOK, WHICH WAS OF UNCLEAR TYPE AND APPEARED TO HAVE BEEN PRESENT FOR MORE THAN THREE YEARS. ON THE SAME DAY THE BARD DENALI INFERIOR VENA CAVA FILTER WAS ATTEMPTED FOR RETRIEVAL. IT WAS CONCLUDED WITH UNSUCCESSFUL REMOVAL OF INFERIOR VENA CAVA FILTER DUE TO SCARED NATURE OF CAPTURE HOOK AGAINST WALL. THE FILTER DEMONSTRATED TO BE BELOW PRIMARY RENAL VEINS DESPITE HIGH PLACEMENT AND THE FILTER COULD PROBABLY BE REMOVED THOUGH DERANGEMENT OF THE FILTER WOULD BE REQUIRED AND POTENTIALLY REQUIREMENT REMOVAL IN MULTIPLE PIECES. AT THIS POINT WAS NOT CLEAR THE RISKS VERSUS BENEFITS OF THIS TYPE OF REMOVAL WERE JUSTIFIED IN THIS PATIENT. HOWEVER, IT WAS RECOMMENDED TO SEE IN FOLLOW-UP FOR CLINICAL SYMPTOMS WHICH MIGHT BE RELATED TO THE INFERIOR VENA CAVA FILTER. AT THIS POINT LEG POSITION APPEARED UNLIKELY TO BE CAUSING PROBLEMS AND NO FRACTURE WAS PRESENT. AROUND, FIVE MONTHS AND TWO WEEKS LATER, THE PATIENT WAS EXPIRED. THE CAUSE OF THE DEATH WAS UNKNOWN. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE FILTER MIGRATION, AND RETRIEVAL DIFFICULTIES. HOWEVER, THE INVESTIGATION IS INCONCLUSIVE FOR FILTER TILT. PER MEDICAL RECORDS, MULTIPLE ATTEMPTS WERE MADE TO ENGAGE THE APEX OF THE FILTER BUT WERE UNSUCCESSFUL DUE TO SCARED NATURE OF CAPTURE HOOK AGAINST WALL. THIS COULD HAVE CONTRIBUTED TO THE RETRIEVAL DIFFICULTIES. HOWEVER, 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. H10: B2,B6, D4(EXPIRY DATE: 12/2016),D10,G3,H6(PATIENT, DEVICE, CONCLUSION) 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. AT SOME TIME POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER TILTED AND MIGRATED TO HIP. THE DEVICE HAS NOT BEEN REMOVED AND THERE WERE NO REPORTED ATTEMPTS MADE TO RETRIEVE THE FILTER. THE PATIENT EXPERIENCED SHARP PAIN IN HIP WHERE THE FILTER HAD MIGRATED; HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
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. AT SOME TIME POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER TILTED AND MIGRATED TO HIP. THE DEVICE HAS NOT BEEN REMOVED AND THERE WERE NO REPORTED ATTEMPTS MADE TO RETRIEVE THE FILTER. THE PATIENT EXPERIENCED SHARP PAIN IN HIP WHERE THE FILTER HAD MIGRATED AND THE PATIENT SUBSEQUENTLY EXPIRED.
MANUFACTURING REVIEW: A LOT HISTORY REVIEW WAS PERFORMED. THIS IS THE ONLY COMPLAINT TO DATE FOR THIS LOT NUMBER. THEREFORE, A DEVICE HISTORY RECORD (DHR) REVIEW IS NOT REQUIRED. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. IMAGES WERE NOT PROVIDED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED. THERE WERE NO DEVICE DEFICIENCIES IDENTIFIED WITHIN THE MEDICAL RECORDS. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE ALLEGED FILTER TILT AND FILTER MIGRATION 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. (EXPIRY DATE: 12/2016).
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. AT SOME TIME POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER TILTED AND MIGRATED TO HIP. THE DEVICE HAS NOT BEEN REMOVED AND THERE WERE NO REPORTED ATTEMPTS MADE TO RETRIEVE THE FILTER. THE PATIENT EXPERIENCED SHARP PAIN IN HIP WHERE THE FILTER HAS MIGRATED; HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 910093 | DENALI JUGULAR SYSTEM | VENA CAVA FILTER | DTK | BARD PERIPHERAL VASCULAR, INC. | DL900J | GFXL1932 | 00801741040795 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Female | Required Intervention| O| D | ASPIRIN, NYSTATIN, CLINDAMYCIN, REGLAN| ASPIRIN, NYSTATIN, CLINDAMYCIN, REGLAN| ASPIRIN, NYSTATIN, CLINDAMYCIN, REGLAN| FISH OIL, CLARITIN AND VITAMIN D3| LOPRESSOR,DEMEROL, DILAUDID, MORPHINE| LOVENOX, GRAVISCON, DICYCLOMINE, NORCO| LOVENOX, GRAVISCON, DICYCLOMINE, NORCO| LOVENOX, GRAVISCON, DICYCLOMINE, NORCO| METOPROLOL, TRILEPTAL, CITALOPRAM, CLONAZEPAM| METOPROLOL, TRILEPTAL, CITALOPRAM, CLONAZEPAM| METOPROLOL, TRILEPTAL, CITALOPRAM, CLONAZEPAM| RANITIDINE, CELEXA, PRAVASTATIN, VITAMIN B12| RANITIDINE, CELEXA, PRAVASTATIN, VITAMIN B12| RANITIDINE, CELEXA, PRAVASTATIN, VITAMIN B12| VITAMIN C, MIRALAX, WELLBUTRIN| VITAMIN C, MIRALAX, WELLBUTRIN| VITAMIN C, MIRALAX, WELLBUTRIN| ZANTAC, CALCIUM,ZYRTEC, VICODIN, BENTYL |