BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

    MDR report key: 5846067 · Received August 4, 2016

    Report

    Report Number
    1820334-2016-00702
    Event Type
    Injury
    Date Received
    August 4, 2016
    Date of Event
    July 6, 2016
    Report Date
    July 8, 2016
    Manufacturer
    COOK INC
    Product Code
    DTK
    UDI-DI
    10827002330174
    PMA / PMN Number
    K072240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CLINICAL ASSESSMENT IMPRESSION: PER COMPLAINT REPORT, THE GUNTHER TULIP IVC FILTER WAS PLACED FOR AN ACR/S1R APPROPRIATE INDICATION OF RISK OF VENOUS THROMBOEMBOLIC DISEASE AND PLANNED SURGERY WITH CONTRAINDICATION TO ANTICOAGULATION. THE INITIAL VENOGRAM DEMONSTRATED A SEVERE S-SHAPED SCOLIOSIS INVOLVING THE THORACOLUMBAR SPINE. THE IVC COURSE MIRRORED THAT OF THE SCOLIOSIS RESULTING IN A LEVOCONVEX CURVATURE WITH THE APEX JUST BELOW THE LEVEL OF THE LEFT RENAL VEIN. THE IVC FILTER WAS DEPLOYED; APPROPRIATELY SO, BELOW THE LEVEL OF THE INFLOW FROM THE LEFT RENAL VEIN IN A FAIRLY STRAIGHT SEGMENT OF THE IVC. HOWEVER, THE HOOK OF THE FILTER EXTENDED TOWARDS THE APEX OF THE CURVATURE OF THE IVC DUE TO THE SCOLIOSIS. ON THE PLACEMENT IMAGES, THE FILTER STILL APPEARS TO BE WELL CENTERED WITHIN THE IVC ON THE AP PROJECTION. THERE WAS NO SIGNIFICANT TILT ON THE VENOGRAPHIC IMAGES OR THE FOLLOW-UP X-RAY IMAGES. THE ULTRASOUND PERFORMED ON SAME-DAY CONFIRMS NO DVT. FOLLOW-UP X-RAYS PERFORMED ON (B)(6) 2016 DEMONSTRATED INTERVAL CORRECTIVE SURGERY FOR THE SEVERE SCOLIOSIS. THIS RESULTED IN SIGNIFICANT IMPROVEMENT IN OVERALL SCOLIOSIS WITH NEAR COMPLETE STRAIGHTENING OF THE THORACOLUMBAR SEGMENT OF THE SPINE. THE POSTERIOR SPINOUS PROCESSES WERE NOT CLEARLY VISUALIZED ON THE AP PROJECTION, AND WERE PRESUMED TO BE REMOVED WITH LOWER LUMBAR SPINE LAMINECTOMIES, AND THEREFORE THE TILT ON THE AP PROJECTION COULD NOT BE CALCULATED. ON THE LATERAL PROJECTION THE TILT WAS STILL INSIGNIFICANT MEASURING APPROXIMATELY 2° ANTERIOR. VENOGRAM AT TIME OF IVC FILTER RETRIEVAL DEMONSTRATED SIGNIFICANT CHANGE IN THE COURSE OF THE IVC IN REFERENCE TO THE INITIAL VENOGRAM. WHEN THE SCOLIOSIS WAS CORRECTED, THIS INTERN STRAIGHTENED THE COURSE OF THE IVC. THE LEVOCONVEX CURVATURE OF THE INFRARENAL IVC CHANGED FROM AN INITIAL LEFT APEX ANGULATION OF 137° TO A LEFT APEX ANGULATION OF 151°. WHEN THIS IVC CONFIGURATION CHANGED THIS IN TURN CONTRIBUTED TO THE LEFTWARD TILT OF THE IVC FILTER TO INCREASE, NOW PLACING THE HOOK OF THE IVC FILTER ESSENTIALLY AGAINST THE LEFT LATERAL WALL OF THE IVC. IN REFERENCE TO THE LUMEN OF THE IVC, AT THIS LEVEL, THE TILT CHANGED FROM 5° OF RIGHTWARD TILT TO 14° OF LEFTWARD TILT, RESULTING IN A TOTAL OF 19° OF CHANGE. SUBTRACTING THE ANGLE OF CHANGE OF THE ACTUAL IVC, THE ANGLE CHANGED BY IVC FILTER WAS ONLY 4°, AND WAS INSIGNIFICANT. BECAUSE THE LOCATION OF THE HOOK WAS NOW ABUTTING THE LEFT LATERAL WALL OF THE IVC, THIS INHIBITED THE LOOP SNARE DEVICE FROM ENGAGING THE HOOK AND RESULTED IN AN UNSUCCESSFUL RETRIEVAL FILTER. ADJUNCT OF MANEUVERS UTILIZING AN ANGIOPLASTY BALLOON AND MULTIPLE DIFFERENT SNARES AND WIRES WERE ATTEMPTED, BUT, PER COMPLAINT REPORT, THE HOOK WAS NEVER ENGAGED IN THE LOOP SNARE DEVICE. IN ADDITION, THERE WAS A SMALL FILLING DEFECT WITHIN THE CONE OF THE FILTER MEASURING LESS THAN 25% OF THE TOTAL CONE VOLUME. GIVEN THE SMALL VOLUME OF THIS FILLING DEFECT, THIS WAS NOT A CONTRAINDICATION TO ATTEMPTED RETRIEVAL. THERE WAS ALSO PENETRATION BY MULTIPLE PRIMARY LEGS AS DETAILED ABOVE. THE CHANGE IN ORIENTATION OF THE IVC MAY HAVE CONTRIBUTED TO THE DEVELOPMENT OF THIS PENETRATION, GIVEN THE SHORT TIMEFRAME IN WHICH THE FILTER WAS IN PLACE. INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, MANUFACTURING INSTRUCTIONS AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. FILTER PERFORATION OF THE VENA CAVA WALL IS A KNOWN RISK REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE. ALSO, PUBLISHED SCIENTIFIC LITERATURE DESCRIBES THAT MANIPULATION IN THE AREA OF FILTER PLACEMENT COULD CONTRIBUTE TO CHANGES TO THE FILTER CONFIGURATION AND PLACEMENT THEREBY POTENTIALLY INITIATE PERFORATION OF THE VENA CAVA WALL. FILTER RETRIEVAL IS OCCASIONALLY DIFFICULT. THIS IS WELL-KNOWN FROM PUBLISHED SCIENTIFIC LITERATURE WHERE FILTER RETRIEVALS ARE REFERRED TO AS SIMPLE VS. COMPLEX. SEVERAL CASE REPORTS PUBLISHED IN SCIENTIFIC LITERATURE DESCRIBE COMPLEX CASES WITH SUCCESSFUL ENDOVASCULAR FILTER RETRIEVALS USING ADDITIONAL, ADVANCED TECHNIQUES. FROM THE PUBLISHED SCIENTIFIC LITERATURE FILTER TILT INSIDE IVC AND/OR EMBEDMENT OF FILTER LEGS OR FILTER HOOK IN THE IVC WALL IS A WELL-KNOWN RISK. BASED ON THE PROVIDED INFORMATION, THE ROOT CAUSE FOR THE PERFORATION OF IVC AND DIFFICULT RETRIEVAL IS CONCLUDED TO BE RELATED TO THE CHANGE IN ORIENTATION OF THE IVC (E.G. OPERATIONAL OR ENVIRONMENTAL CONTEXT). WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    (B)(6) MAJOR DIFFICULTY ATTEMPTING TO RETRIEVE THE FILTER. ON (B)(6) 2016 DURING THE INDEX PROCEDURE A GUNTHER TULIP FILTER WAS PLACED. GPN G33017, LOT # 6011568. THE INFERIOR VENA CAVA (IVC) DIAMETER AT THE INTENDED FILTER LOCATION WAS 25.78 MM. THERE WAS NO IVC ANATOMIC ANOMALY OR PRESENCE OF THROMBUS IN THE IVC PRIOR TO FILTER PLACEMENT. USING THE RIGHT INTERNAL JUGULAR VEIN AS THE ACCESS SITE, A GUNTHER TULIP FILTER (GPN G33017, LOT # 6011568 WAS DEPLOYED AT THE INTENDED LOCATION IN THE IVC INFRARENAL SITE AND IN A LOCATION SUITABLE TO PROVIDE SUFFICIENT MECHANICAL PROTECTION AGAINST PULMONARY EMBOLISM (PE). THE FILTER NEITHER DEPLOYED PREMATURELY NOR DID THE FILTER JUMP UPON DEPLOYMENT. THERE WAS NO EVIDENCE OF FILTER FRACTURE, DEFORMATION, OR MIGRATION. THERE WAS NO EXTRAVASATION OF CONTRAST OR FILTER LEGS APPEARING OUTSIDE THE COLUMN OF CONTRAST AFTER FILTER PLACEMENT. THE FILTER ANGLE OF TILT WAS <6 DEGREES. CORE LAB ANALYSIS OF THE PLACEMENT PROCEDURE VENACAVAGRAM REVEALED NO IVC ANATOMIC ANOMALY OR PRESENCE OF THROMBUS IN THE IVC PRIOR TO FILTER PLACEMENT. THE FILTER WAS PLACED IN THE IVC INFRARENAL SITE, AND THE IVC DIAMETER AT THE FILTER LOCATION WAS 19.1 MM. THERE WAS NO EVIDENCE OF FILTER MIGRATION, EXTRAVASATION OF CONTRAST, OR DEFORMATION. FILTER LEGS DID APPEAR OUTSIDE THE COLUMN OF CONTRAST AFTER FILTER PLACEMENT. THE ANGLE OF FILTER TILT IN THE AP VIEW WAS 2.1 DEGREES. THERE IS NO SITE POST-PROCEDURE X-RAY REPORT AVAILABLE. CORE LAB REVIEW OF THE POST-PROCEDURE X-RAY DATED (B)(6) 2016 (DAY OF PROCEDURE), INDICATED NO EVIDENCE OF FILTER FRACTURE, DEFORMATION, EMBOLIZATION, OR MIGRATION. THE ANGLE OF FILTER TILT IN THE AP VIEW WAS 1.6 DEGREES AND 2.6 DEGREES IN THE LAT VIEW. ON (B)(6) 2016 (30 DAYS POST-PROCEDURE), THE PATIENT UNDERWENT AN UNSUCCESSFUL FILTER RETRIEVAL. THE FILTER WAS NO LONGER CLINICALLY NEEDED. THE PHYSICIAN INDICATED THERE WERE MAJOR DIFFICULTIES ATTEMPTING TO REMOVE THE FILTER AND IT WAS NOT RETRIEVED. PRE-RETRIEVAL ATTEMPT, THERE WAS <=25% THROMBUS OCCUPYING THE FILTER CONE AND FILTER LEGS APPEARED OUTSIDE THE COLUMN OF CONTRAST. A GUNTHER TULIP RETRIEVAL SET WAS USED; THERE WERE TWO ACCESS SITES USED, THE RIGHT INTERNAL JUGULAR VEIN AND THE RIGHT COMMON FEMORAL VEIN. THE PHYSICIAN NOTED, "MULTIPLE ATTEMPTS WERE MADE TO SNARE THE TOP HOOK OF THE INFERIOR VENA CAVA FILTER DEVICE. THIS INCLUDED UTILIZING ACCESS FROM THE RIGHT COMMON FEMORAL VEIN, BALLOON DISPLACEMENT OF THE FILTER, AND MULTIPLE WIRE AND SNARE COMBINATIONS." THE REASONS FOR THE INABILITY TO RETRIEVE THE FILTER WERE: HOOK ORIENTED TOWARDS VESSEL WALL AND KOOK EMBEDDED IN VESSEL WALL AND UNABLE TO GRASP. THERE IS NO PRE-RETRIEVAL X-RAY AT THIS TIME. ADDENDUM REGARDING RESULTS OF X-RAY BELOW. ADDENDUM 8JUL2016: ON (B)(6) 2016 ON THE PRE-RETRIEVAL X-RAY, THE SITE REPORTED NO EVIDENCE OF FILTER FRACTURE, EMBOLIZATION, OR MIGRATION. THERE IS EVIDENCE OF FILTER TILT OF >=16 DEGREES. CORE LAB ASSESSMENT OF THE PRE-RETRIEVAL X-RAY IS NOT YET AVAILABLE. THE PATIENT REMAINS IN THE STUDY.

    Description of Event or Problem · 1

    (B)(6) MAJOR DIFFICULTY ATTEMPTING TO RETRIEVE THE FILTER. ON (B)(6) 2016 DURING THE INDEX PROCEDURE A GUNTHER TULIP FILTER WAS PLACED. GPN G33017, LOT # 6011568. THE INFERIOR VENA CAVA (IVC) DIAMETER AT THE INTENDED FILTER LOCATION WAS 25.78 MM. THERE WAS NO IVC ANATOMIC ANOMALY OR PRESENCE OF THROMBUS IN THE IVC PRIOR TO FILTER PLACEMENT. USING THE RIGHT INTERNAL JUGULAR VEIN AS THE ACCESS SITE, A GUNTHER TULIP FILTER (GPN G33017, LOT # 6011568 WAS DEPLOYED AT THE INTENDED LOCATION IN THE IVC INFRARENAL SITE AND IN A LOCATION SUITABLE TO PROVIDE SUFFICIENT MECHANICAL PROTECTION AGAINST PULMONARY EMBOLISM (PE). THE FILTER NEITHER DEPLOYED PREMATURELY NOR DID THE FILTER JUMP UPON DEPLOYMENT. THERE WAS NO EVIDENCE OF FILTER FRACTURE, DEFORMATION, OR MIGRATION. THERE WAS NO EXTRAVASATION OF CONTRAST OR FILTER LEGS APPEARING OUTSIDE THE COLUMN OF CONTRAST AFTER FILTER PLACEMENT. THE FILTER ANGLE OF TILT WAS <6 DEGREES. CORE LAB ANALYSIS OF THE PLACEMENT PROCEDURE VENACAVAGRAM REVEALED NO IVC ANATOMIC ANOMALY OR PRESENCE OF THROMBUS IN THE IVC PRIOR TO FILTER PLACEMENT. THE FILTER WAS PLACED IN THE IVC INFRARENAL SITE, AND THE IVC DIAMETER AT THE FILTER LOCATION WAS 19.1 MM. THERE WAS NO EVIDENCE OF FILTER MIGRATION, EXTRAVASATION OF CONTRAST, OR DEFORMATION. FILTER LEGS DID APPEAR OUTSIDE THE COLUMN OF CONTRAST AFTER FILTER PLACEMENT. THE ANGLE OF FILTER TILT IN THE AP VIEW WAS 2.1 DEGREES. THERE IS NO SITE POST-PROCEDURE X-RAY REPORT AVAILABLE. CORE LAB REVIEW OF THE POST-PROCEDURE X-RAY DATED (B)(6) 2016 (DAY OF PROCEDURE), INDICATED NO EVIDENCE OF FILTER FRACTURE, DEFORMATION, EMBOLIZATION, OR MIGRATION. THE ANGLE OF FILTER TILT IN THE AP VIEW WAS 1.6 DEGREES AND 2.6 DEGREES IN THE LAT VIEW. ON (B)(6) 2016 (30 DAYS POST-PROCEDURE), THE PATIENT UNDERWENT AN UNSUCCESSFUL FILTER RETRIEVAL. THE FILTER WAS NO LONGER CLINICALLY NEEDED. THE PHYSICIAN INDICATED THERE WERE MAJOR DIFFICULTIES ATTEMPTING TO REMOVE THE FILTER AND IT WAS NOT RETRIEVED. PRE-RETRIEVAL ATTEMPT, THERE WAS <=25% THROMBUS OCCUPYING THE FILTER CONE AND FILTER LEGS APPEARED OUTSIDE THE COLUMN OF CONTRAST. A GUNTHER TULIP RETRIEVAL SET WAS USED; THERE WERE TWO ACCESS SITES USED, THE RIGHT INTERNAL JUGULAR VEIN AND THE RIGHT COMMON FEMORAL VEIN. THE PHYSICIAN NOTED, ¿MULTIPLE ATTEMPTS WERE MADE TO SNARE THE TOP HOOK OF THE INFERIOR VENA CAVA FILTER DEVICE. THIS INCLUDED UTILIZING ACCESS FROM THE RIGHT COMMON FEMORAL VEIN, BALLOON DISPLACEMENT OF THE FILTER, AND MULTIPLE WIRE AND SNARE COMBINATIONS.¿ THE REASONS FOR THE INABILITY TO RETRIEVE THE FILTER WERE: HOOK ORIENTED TOWARDS VESSEL WALL AND KOOK EMBEDDED IN VESSEL WALL AND UNABLE TO GRASP. THERE IS NO PRE-RETRIEVAL X-RAY AT THIS TIME. ADDENDUM REGARDING RESULTS OF X-RAY BELOW ADDENDUM 8JUL2016: ON (B)(6) 2016 ON THE PRE-RETRIEVAL X-RAY, THE SITE REPORTED NO EVIDENCE OF FILTER FRACTURE, EMBOLIZATION, OR MIGRATION. THERE IS EVIDENCE OF FILTER TILT OF >=16 DEGREES. CORE LAB ASSESSMENT OF THE PRE-RETRIEVAL X-RAY IS NOT YET AVAILABLE. THE PATIENT REMAINS IN THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499856 GUNTHER TULIP JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC N/A 10827002330174

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention