COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
Report
- Report Number
- 3002808486-2018-01281
- Event Type
- Injury
- Date Received
- November 5, 2018
- Date of Event
- October 11, 2018
- Report Date
- November 21, 2018
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- UDI-DI
- 10827002345048
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4) NAME AND ADDRESS FOR IMPORTER SITE: (B)(6). REGISTRATION NO.: (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: INVESTIGATION IS BASED ON EVENT DESCRIPTION AND IMAGE REVIEW. IT WAS REPORTED THAT THE FILTER HAD MIGRATED SOUTH AND COULD NOT BE RETRIEVED. "PATIENT IS OKAY", BUT "IS NOT HAPPY TO HAVE THE FILTER LEFT IN". CELECT PLATINUM IVC FILTER WAS PLACED FOR THE INDICATION OF CAVAL THROMBUS. THIS WAS CONFIRMED ON THE INITIAL VENOGRAM DEMONSTRATING SIGNIFICANT CAVAL THROMBUS BURDEN EXTENDING NEARLY TO THE INFLOW OF THE RENAL VEINS. GIVEN THE EXTENT OF THE CAVAL THROMBUS, A SUPRARENAL LOCATION WAS CHOSEN FOR DEPLOYMENT OF THE FILTER. THE SUPRARENAL IVC MEASURES WITHIN THE UPPER LIMITS OF IVC FILTER DIAMETER SPECIFIED BY THE IFU. AS NOTED ON THE INITIAL VENOGRAM, THE RIGHT RENAL VEIN OSTIUM IS VERY LARGE MEASURING UP TO 22 MM IN DIAMETER, AND JOINS THE IVC AT A FAIRLY STEEP ANGLE. WHEN CONTRAST WAS INJECTED IN THE SUPRARENAL LOCATION, NEARLY ALL OF THE CONTRAST WAS SEEN EXTENDING INTO THE RIGHT RENAL VEIN, AND NOT THE IVC. THIS SUGGESTS THAT THE DEPLOYMENT SHEATH IS EITHER ANGLED MORE POSTERIORLY, AT THE OSTIUM OF THE RIGHT RENAL VEIN, OR THAT THE RENAL VEIN OSTIUM IS DISTENDED OPEN DUE TO HIGH FLOW WHILE THE IVC LUMEN IS COLLAPSED DUE TO LOW FLOW FROM THE LARGE CAVAL THROMBUS. THE POST PLACEMENT VENOGRAM CONTINUES TO DEMONSTRATE THIS CONFIGURATION WITH INJECTION OF CONTRAST PRIMARILY OPACIFYING THE RIGHT RENAL VEIN, AND NOT THE IVC. GIVEN THE RENAL VEIN INSERTS MORE POSTERIORLY ON THE IVC, AS CONFIRMED ON LATER SAGITTAL CT SCAN, ON THE SINGLE PROJECTION OBTAINED DURING THE VENOGRAM, IT IS VERY DIFFICULT TO DETERMINE THE EXACT POINT IN WHICH THE RENAL VEIN JOINS THE IVC. GIVEN THE APPEARANCE OF THE FILTER AFTER DEPLOYMENT, IT IS LIKELY THAT THE RIGHT LATERAL MOST AND POSTERIOR DIRECTED FEET ARE WITHIN THE RIGHT RENAL VEIN OSTIUM WHILE THE LEFT LATERAL MOST AND ANTERIOR FEET ARE WITHIN THE IVC. COMPLICATIONS SIMILAR TO THIS HAS BEEN DESCRIBED IN THE LITERATURE WHERE IVC FILTERS HAVE BEEN INADVERTENTLY DEPLOYED WITHIN THE GONADAL VEIN OR ACCESSORY PARALUMBAR VEINS DUE TO THEIR SIMILAR ORIENTATION TO THE IVC. THERE IS NO EVIDENCE OF SIGNIFICANT TILT ON THIS STUDY AND THE FILTER FEET TERMINATE AT THE L2/L3 VERTEBRAL BODY LEVEL. FOLLOW-UP VENOGRAM PERFORMED APPROXIMATELY 8 MONTHS AFTER IMPLANTATION, DEMONSTRATES THE FILTER ON THE INITIAL X-RAY WITH A NEW SIGNIFICANT LEFTWARD TILT RELATIVE TO THE POSTERIOR SPINOUS PROCESSES. HOWEVER, THIS TILT SIGNIFICANTLY VARIES DEPENDING ON THE PHASE OF RESPIRATION, AS REPEAT X-RAY DEMONSTRATES NO SIGNIFICANT TILT RELATIVE TO THE POSTERIOR SPINOUS PROCESSES. VENOGRAM OF THE LEFT RENAL VEIN REFLUXES INTO THE IVC DEMONSTRATING MUCH OF THE FILTER DOES NOT APPEAR TO BE WITHIN THE IVC. WITH CONTRAST INJECTION INTO THE RIGHT RENAL VEIN, THE FILTER APPEARS TO BE MORE CENTERED WITHIN THE RENAL VEIN AND THEN THE IVC. IN ADDITION, THERE IS CAUDAL MIGRATION OF THE IVC FILTER BY APPROXIMATELY 3 CM, MEETING THE DEFINITION OF MIGRATION. AS CONFIRMED ON FOLLOW-UP CT SCAN, DATED SEVEN MONTHS AFTER THE FOLLOW-UP VENOGRAM, THE FILTER IS PREDOMINANTLY LOCATED WITHIN THE RIGHT RENAL VEIN WITH AT LEAST TWO OF THE PRIMARY FILTER LEGS AND MULTIPLE SECONDARY LEGS EXTENDING INTO AND THROUGH THE RIGHT RENAL VEIN, WHILE THE REMAINING TWO PRIMARY FILTER LEGS AND ASSOCIATED SECONDARY LEGS AT THE 12:00 AND 3:00 REGION REMAINED IN THE IVC LUMEN, EVENTUALLY EXTENDING THROUGH THE WALL OF THE IVC. THE CAUDAL MIGRATION OF THE IVC FILTER AND PENETRATION THROUGH THE RIGHT RENAL VEIN IS LIKELY RELATED TO THE INITIAL DEPLOYMENT OF THE FILTER PARTIALLY WITHIN THE RIGHT RENAL VEIN AND PARTIALLY WITHIN THE IVC. AS DEMONSTRATED ON THE FOLLOW-UP VENOGRAM, THE TILT OF THE FILTER SIGNIFICANTLY CHANGES DEPENDING ON THE DEGREE OF RESPIRATION AS PORTION OF THE FILTER IS FIXED TO THE IVC AND THE OTHER PORTION WITHIN THE RENAL VEIN, AND THESE 2 STRUCTURES DO NOT NECESSARILY MOVE TO THE SAME EXTENT DURING RESPIRATIONS. IT IS HYPOTHESIZED THAT THIS ALTERATION IN MOVEMENT RESULTED IN A RATCHETING CONFIGURATION OF THE FILTER, RESULTING IN THE CAUDAL MIGRATION AND CONFIGURATION OBSERVED ON THE CT SCAN. THERE ARE FOUR GRADE 3 INTERACTIONS WITH THE VARIOUS STRUCTURES INCLUDING THE DUODENUM, VERTEBRAL BODY, PSOAS MUSCLE AND RENAL PARENCHYMA. THERE IS SOME HETEROTOPIC BONE FORMATION AND MINIMAL STRANDING ADJACENT TO THE INTERACTION WITH THE VERTEBRAL BODY SUGGESTING AN ELEMENT OF INFLAMMATORY CHANGE THAT IS PRESENT, ALTHOUGH NO CLINICAL DISCUSSION OF SYMPTOMS RELATED TO THIS WAS PRESENT IN THE COMPLAINT REPORT. THE GRADE 3 INTERACTIONS ARE AGAIN LIKELY RELATED TO THE CAUDAL MIGRATION AND INITIAL PLACEMENT OF THE FILTER, WHICH OVERALL IS RELATED TO THE PROCEDURE ITSELF AS WELL AS THE PATIENT'S UNDERLYING ANATOMY AND DISEASE PROCESS. THIS CIRCUMSTANCE MAY HAVE BEEN AVOIDED IF THE FILTER WAS INITIALLY DEPLOYED SLIGHTLY HIGHER IN THE SUPRARENAL IVC TAKING CARE NOT TO DEPLOY ANY OF THE PRIMARY FILTER LEGS WITHIN THE RIGHT RENAL VEIN OSTIUM. IMPORTANTLY, THE IVC FILTER IS NOT PROVIDING ANY CLINICAL BENEFIT IN THE CURRENT LOCATION AND RETRIEVAL SHOULD BE CONSIDERED TO HELP AVOID WORSENING PENETRATION OR OTHER FILTER RELATED COMPLICATIONS. MANIPULATION IN THE AREA OF THE FILTER IMPLANT MAY CAUSE MIGRATION OR CONTRIBUTE TO CHANGES IN THE FILTER CONFIGURATION AND PLACEMENT. VENA CAVA WALL PERFORATION IS A KNOWN POTENTIAL COMPLICATION OF VENA CAVA FILTERS. BOTH SYMPTOMATIC AND ASYMPTOMATIC EVENTS HAVE BEEN REPORTED. AMONG OTHER CAUSES, VENA CAVA WALL PERFORATION MAY INADVERTENTLY BE INITIATED BY IMPROPER DEPLOYMENT, EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IMPLANTED FILTER (E.G., A SURGICAL PROCEDURE IN THE VICINITY OF A FILTER) AND (OR) PROCEDURES THAT INVOLVE OTHER DEVICES BEING PASSED THROUGH AN IN SITU FILTER. NO EVIDENCE TO SUGGEST THAT THIS FILTER WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT TIT DID NOT PERFORM AS INTENDED. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113 G5) SIMILAR TO DEVICE UNDER PMA/510(K): K121629. INVESTIGATION IS STILL IN PROGRESS.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: FILTER WAS IMPLANTED (B)(6) 2017 IT HAS MIGRATED SOUTH. CANNOT BE RETRIEVED. PATIENT IS OKAY. THERE WAS EXTENSIVE THROMBUS IN THE IVC UP TO LEVEL OF THE RENALS. THE FILTER WAS IMPLANTED ABOVE RENALS BUT THE IVC WAS QUITE CONICAL HERE. THE FILTER HAS MIGRATED DOWN INTO THE RENAL VEIN. ADDITIONAL INFORMATION RECEIVED (B)(6) 2018: FILTER IMPLANTED ABOVE RENALS DUE TO EXTENSIVE THROMBUS AT RENAL LEVEL, VIA RIJV ACCESS. AWAITING ANGIO IMAGES BUT SATISFACTORY AT TIME OF DEPLOYMENT. THE FILTER HAS SUBSEQUENTLY MIGRATED SOUTH AND IS NOW IN SEGMENTAL RENAL VEIN. IT IS THOUGHT TOO DANGEROUS TO RETRIEVE THIS FILTER. ADDITIONAL INFORMATION RECEIVED (B)(6) 2018: SIGNIFICANT DVT WITH IVC THROMBUS EXTENDING UP TO THE RENAL VEINS. PATIENT ALSO HAS GUILLAIN-BARRE. SUPRARENAL FILTER INSERTED (B)(6) 2017, EXTENDED REHABILITATION. ATTEMPTED RETRIEVAL (B)(6) 2018. FILTER THOUGHT TO BE THROMBOSED. PATIENT LOST FOR FOLLOW-UP. PATIENT OUTCOME: RECENT CT (B)(6) 2018. PHYSICIAN WAS OF THE OPINION THE FILTER SHOULD BE LEFT IN. PATIENT REPORTS STRANGE INTRAABDOMINAL SENSATION. PATIENT WAS TOLD THAT THE FILTER IS NOT IN IDEAL LOCATION AND THINKS IT MIGHT BE THAT AND WANTS IT REMOVED. IT DOESN¿T LOOK POSSIBLE TO MOVE WITHOUT COMPROMISING THE PATIENT. IT IS BELIEVED THAT PHYSICIANS HAVE NO PLAN TO DO ANYTHING FURTHER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 880394 | COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE | E3550510 | 10827002345048 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Life Threatening |