DENALI JUGULAR SYSTEM
Report
- Report Number
- 2020394-2023-01078
- Event Type
- Malfunction
- Date Received
- November 21, 2023
- Date of Event
- October 21, 2019
- Report Date
- August 13, 2024
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DTK
- PMA / PMN Number
- K130366
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
OUR FIRM RECEIVED AN FDA EMAIL CORRESPONDENCE ON 06-AUG-2024 FROM MDR DATA SYSTEMS TEAM, REBEKAH SYKES, INDICATING THAT THE INFORMATION (SPECIFICALLY THE UNIQUE DEVICE IDENTIFIER (UDI) INFORMATION IN SECTION D) OF THE PREVIOUSLY SUBMITTED FDA FORM 3500A, WAS INCORRECT AND A REQUEST WAS MADE TO SUBMIT SUPPLEMENTAL REPORT(S) WITH THE ENTIRE UDI NUMBER INCLUDING THE DI AND PI FIELDS, ALL NUMBERS, LETTERS, PARENTHESES, AND SYMBOLS IN THE ¿UNIQUE DEVICE IDENTIFIER (UDI) #¿ FIELDS. THIS SUPPLEMENTAL REPORT IS IN RESPONSE TO THAT REQUEST. **UDI RELATED DATA QUALITY UPDATES ONLY** D4: MEDICAL DEVICE EXPIRATION DATE- 10/31/2022 D4: UDI- (B)(4). G4: K240257, K160866, K143208, K130366.
H10: MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUIRED AS THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS PRODUCT AND LOT. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE MEDICAL RECORDS INCLUDED IMAGES. THE IMAGE REVIEW WAS DOCUMENTED IN THE MEDICAL RECORDS. ONE FLUOROSCOPIC IMAGE WAS REVIEWED. THE IMAGE DEPICTS THE DEPLOYED VENA CAVA FILTER. A GUIDE WIRE HAS BEEN INTRODUCED FROM THE JUGULAR VEIN. DEPLOYED INTRAVASCULAR COILS ARE NOTED. IT IS NOT KNOWN WHETHER THIS IMAGE REPRESENTS AN ATTEMPT TO REPOSITION/REMOVE THE FILTER AT THE TIME OF DEPLOYMENT OR AT SOME LATER POINT IN TIME. IN THE ABSENCE OF CONTRAST, THE FILTER¿S LOCATION WITHIN THE VENA CAVA CANNOT BE DETERMINED. WHETHER MIGRATION OCCURRED AT THE TIME OF DEPLOYMENT CANNOT BE DETERMINED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED. THROUGH THE RIGHT INTERNAL JUGULAR VENOUS ACCESS, BARD DENALI IVC FILTER WAS DEPLOYED WITHIN THE INFRARENAL SEGMENT OF THE INFERIOR VENA CAVA FOR A PATIENT WITH HISTORY OF HYPERCOAGULABLE STATE AND PERIOPERATIVE FILTER PLACEMENT. FOLLOWING DEPLOYMENT OF IVC FILTER, THE CEPHALAD CONE OF THE FILTER IS IMMEDIATELY BELOW THE LEVEL OF THE RENAL VEINS, WITH THE FILTER NOTED ABOVE THE LEVEL OF THE VENOUS CONFLUENCE IN GOOD POSITION. ON THE SAME DAY, A COMPUTED TOMOGRAPHY (CT) OF ABDOMEN AND PELVIS STUDY WAS PERFORMED FOR RIGHT LOWER QUADRANT ABDOMINAL PAIN RADIATES TO BACK. THE STUDY SHOWED FILTER WAS NOTED WITH SUPERIOR APEX BELOW THE CONFLUENCE OF THE RENAL VEINS WITH IVC. ON THE NEXT DAY, A COMPUTED TOMOGRAPHY (CT) OF ABDOMEN AND PELVIS STUDY WAS PERFORMED FOR LOW BLOOD PRESSURE AND LOWER RIGHT ABDOMINAL PAIN. THE STUDY SHOWED FILTER WAS NOTED. AT THE LEVEL OF THE FILTER THERE HAS BEEN INTERVAL INCREASE IN CIRCUMFERENCE OF THE SURROUNDING IVC WITH A NEW LARGE RETROPERITONEAL HEMORRHAGE EXTENDING INFERIORLY JUST ANTERIOR TO THE NORMAL APPEARING PSOAS MUSCLE. GIVEN THE RECENT FILTER PLACEMENT, FINDINGS ARE MOST CONSISTENT WITH IVC RUPTURE. AROUND TWO DAYS LATER, A COMPUTED TOMOGRAPHY ANGIOGRAM OF ABDOMEN AND PELVIS STUDY WAS PERFORMED FOR IVC INJURY. THE STUDY SHOWED INFRARENAL FILTER WAS NOTED. THE RIGHT EXTERNAL ILIAC VEIN DEMONSTRATES FOCAL FILLING DEFECT SUGGESTING UNDERLYING DVT. THERE ARE ADDITIONAL AREAS OF POSSIBLE VENOUS THROMBUS INFERIOR TO THE FILTER IN THE DISTENDED IVC. ON THE NEXT DAY, AN INFERIOR VENACAVOGRAM WAS PERFORMED DOCUMENTING IVC THROMBUS WITHIN THE ILIAC VEINS EXTENDING UP TO THE IVC FILTER. DUE TO EXTENT OF THE THROMBUS THE FILTER WAS LEFT IN PLACE. AROUND TWO DAYS LATER, A COMPUTED TOMOGRAPHY (CT) OF ABDOMEN AND PELVIS WITHOUT CONTRAST STUDY WAS PERFORMED FOR ABDOMINAL DISTENSION AND IVC INJURY. THE STUDY SHOWED THAT IVC FILTER WAS NOTED. ON THE SAME DAY, A NON-SELECTIVE ABDOMINAL AORTOGRAM WAS PERFORMED FOR ABDOMINAL PAIN WITH HYPOTENSION. THE STUDY SHOWED MASSIVE HEMORRHAGE ARISING FROM THE THIRD LUMBAR ARTERY AT THE LEVEL OF THE LEGS OF THE BARD DENALI IVC FILTER. RETHROMBOSIS OF THE ILIAC VEINS AND THE IVC BELOW THE LEVEL OF THE FILTER. ON THE SAME DAY, BILATERAL ILIAC AND IVC VENOGRAM WITH THROMBOLYTIC THERAPY WAS PERFORMED FOR EXTENSIVE IVC AND LOWER EXTREMITY DEEP VEIN THROMBOSIS. NEXT DAY, A COMPUTED TOMOGRAPHY ANGIOGRAM OF ABDOMEN AND PELVIS WAS PERFORMED FOR BLEEDING. THE STUDY SHOWED IVC FILTER WAS NOTED IN UNCHANGED POSITION OVER THE INTERVAL. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR FILTER MIGRATION. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. H10: D4 (EXPIRY DATE: 10/2022). H11: SECTION A THROUGH F ¿ THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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 : DEVICE NOT RETURNED.
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS DEPLOYED IN A PATIENT AFTER BEING DIAGNOSED WITH HYPERCOAGULABLE STATE. ON THE SAME DAY POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER WAS MIGRATED. THE DEVICE HAS NOT BEEN REMOVED, AND THERE HAVE BEEN NO REPORTED ATTEMPTS MADE TO RETRIEVE THE FILTER. THERE WAS NO REPORTED PATIENT INJURY.
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS DEPLOYED IN A PATIENT AFTER BEING DIAGNOSED WITH HYPERCOAGULABLE STATE. ON THE SAME DAY POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER WAS MIGRATED. THE DEVICE HAS NOT BEEN REMOVED, AND THERE HAVE BEEN NO REPORTED ATTEMPTS MADE TO RETRIEVE THE FILTER. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1797766 | DENALI JUGULAR SYSTEM | VENA CAVA FILTER | DTK | BARD PERIPHERAL VASCULAR, INC. | GFDW1753 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Female |