GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
Report
- Report Number
- 1820334-2021-02484
- Event Type
- Injury
- Date Received
- November 11, 2021
- Report Date
- November 11, 2021
- Manufacturer
- COOK INC
- Product Code
- DTK
- UDI-DI
- 10827002330174
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
THE PREVIOUS MEDWATCH REPORT WAS SUBMITTED BY WILLIAM COOK EUROPE UNDER MANUFACTURER REPORT REFERENCE# 3002808486-2021-01306 WCE MDR REPORT NUMBER SEQUENCE. ADDITIONAL INFORMATION PROVIDED DETERMINED THAT THIS DEVICE WAS MANUFACTURED BY COOK INC. WITH THE SUBMISSION OF THIS INITIAL MEDWATCH REPORT, COOK INC. INFORMS THAT ALL FUTURE SUBMISSIONS REGARDING THIS COMPLAINT WILL BE HANDLED UNDER THE MANUFACTURER REPORT REFERENCE # REFERENCED IN G8 OF THIS INITIAL MEDWATCH REPORT. OCCUPATION: NON-HEALTHCARE PROFESSIONAL. PMA/510K: K072240. INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. THE REPORTED ALLEGATIONS HAVE BEEN FURTHER INVESTIGATED BASED ON THE INFORMATION PROVIDED TO DATE. THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: ORGAN/VENA CAVA (VC) PERFORATION, COMPLEX RETRIEVAL W/EMBOLIZATION, RIGHT ATRIUM (MIGRATION), ANXIETY, FEAR. FILTER INTERACTS WITH IVC WALL, E.G. PENETRATION/PERFORATION/EMBEDMENT. THIS MAY BE EITHER SYMPTOMATIC OR ASYMPTOMATIC. POTENTIAL CAUSES MAY INCLUDE IMPROPER DEPLOYMENT; AND (OR) EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IN-SITU FILTER (E.G., A SURGICAL OR ENDOVASCULAR PROCEDURE IN THE VICINITY OF A FILTER). POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: TRAUMA TO ADJACENT STRUCTURES, VASCULAR TRAUMA, VENA CAVA PERFORATION, VENA CAVA PENETRATION. PHYSICIAN PRACTICE GUIDELINES AND PUBLISHED GUIDANCE FROM REGULATORY AGENCIES RECOMMEND THAT PATIENTS WITH INDWELLING FILTERS UNDERGO ROUTINE FOLLOW-UP. THE RISKS/BENEFITS OF FILTER RETRIEVAL SHOULD BE CONSIDERED FOR EACH PATIENT DURING FOLLOW-UP. ONCE PROTECTION FROM PE IS NO LONGER NECESSARY, FILTER RETRIEVAL SHOULD BE CONSIDERED. FILTER RETRIEVAL SHOULD BE ATTEMPTED WHEN FEASIBLE AND CLINICALLY INDICATED. FILTER RETRIEVAL IS A PATIENT-SPECIFIC, CLINICALLY COMPLEX DECISION; THE DECISION TO REMOVE A FILTER SHOULD BE BASED ON EACH PATIENT¿S INDIVIDUAL RISK/BENEFIT PROFILE (E.G., A PATIENT¿S CONTINUED NEED FOR PROTECTION FROM PE COMPARED TO THEIR EXPERIENCE WITH AND (OR) ONGOING RISK OF EXPERIENCING FILTER-RELATED COMPLICATIONS). FOR ALL RETRIEVABLE IVC FILTERS, RETRIEVAL BECOMES MORE CHALLENGING WITH TIME, AND THIS IS COMMONLY DUE TO ENCAPSULATION OF THE FILTER LEGS OR HOOK (IN A TILTED FILTER) BY TISSUE INGROWTH. THE FILTER IS DESIGNED TO BE RETRIEVED WITH THE GÜNTHER TULIP VENA CAVA FILTER RETRIEVAL SET. IT MAY ALSO BE RETRIEVED WITH THE CLOVERSNARE® VASCULAR RETRIEVER. COOK HAS NOT PERFORMED TESTING TO EVALUATE THE SAFETY OR EFFECTIVENESS OF FILTER RETRIEVAL USING OTHER RETRIEVAL SYSTEMS OR TECHNIQUES. THE PUBLISHED CLINICAL LITERATURE INCLUDES DESCRIPTIONS OF ALTERNATIVE TECHNIQUES FOR FILTER RETRIEVAL; USE OF THESE TECHNIQUES VARIES ACCORDING TO PHYSICIAN EXPERIENCE, PATIENT ANATOMY, AND FILTER POSITION. THE SAFETY OR EFFECTIVENESS OF THESE ALTERNATIVE RETRIEVAL TECHNIQUES HAS NOT BEEN ESTABLISHED. SPECIFIC FOR ¿EMBEDDED¿ A FILTER THAT IS EMBEDDED IN THE WALL OF THE IVC MAY BE DIFFICULT TO RETRIEVE. FOR ALL RETRIEVABLE IVC FILTERS, RETRIEVAL BECOMES MORE CHALLENGING WITH TIME, AND THIS IS COMMONLY DUE TO ENCAPSULATION OF THE FILTER LEGS OR HOOK (IN A TILTED FILTER) BY TISSUE INGROWTH. FILTER OR FILTER FRAGMENT MIGRATION AND (OR) EMBOLIZATION (E.G., MOVEMENT TO THE HEART OR LUNGS) HAS BEEN REPORTED. FILTER OR FILTER FRAGMENT MOVEMENT HAS OCCURRED IN BOTH THE CRANIAL AND CAUDAL DIRECTION AND MAY BE EITHER SYMPTOMATIC OR ASYMPTOMATIC. POTENTIAL CAUSES MAY INCLUDE FILTER PLACEMENT IN IVCS WITH DIAMETERS SMALLER OR LARGER THAN THOSE SPECIFIED IN THESE INSTRUCTIONS FOR USE; IMPROPER DEPLOYMENT; DEPLOYMENT INTO THROMBUS; DISLODGEMENT DUE TO LARGE THROMBUS BURDENS; AND (OR) EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IN SITU FILTER (E.G., A SURGICAL OR ENDOVASCULAR PROCEDURE IN THE VICINITY OF A FILTER). POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: FILTER MIGRATION, TRAUMA TO ADJACENT STRUCTURES. UNKNOWN IF THE REPORTED ANXIETY AND FEAR ARE DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. A TOTAL OF 20 DEVICES WERE MANUFACTURED IN THE REPORTED LOT. TO DATE, ONE OTHER COMPLAINT HAS BEEN REPORTED AGAINST THE LOT. THE ASSOCIATED WORK ORDER WAS REVIEWED. NO RELATED/RELEVANT NOTES WERE DOCUMENTED. THE DEVICE IS MANUFACTURED AND INSPECTED ACCORDING TO SPECIFICATIONS. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT THE FILTER DID NOT PERFORM AS INTENDED, E.G. INTENDED FOR THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PLACEMENT IN THE VENA CAVA. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2012 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO PULMONARY EMBOLISM (PE) . PATIENT IS ALLEGING ORGAN AND VENA CAVA PERFORATION, PERFORATION ABUTTING ORGAN, AND COMPLEX RETRIEVAL WITH EMBOLIZATION, RIGHT ATRIUM. PATIENT FURTHER ALLEGES " THE IVC FILTER IMPLANTED IN MY BODY PERFORATED MY VENA CAVA, WITH ONE STRUT PERFORATING MY AORTA AND A SECOND PERFORATING MY DUODENUM; THIS CAUSED ME TO LIVE WITH FEAR AND ANXIETY. DUE TO THE FILTER¿S FAILURE I UNDERWENT A COMPLEX SURGICAL PROCEDURE TO HAVE IT REMOVED. DURING THIS PROCEDURE, MY FILTER EMBOLIZED TO MY RIGHT ATRIUM. FURTHER, A PORTION OF AN [NON-COOK SNARE DEVICE] BROKE OFF AND MIGRATED TO MY RIGHT VENTRICLE". PATIENT ALLEGES SUCCESSFUL PERCUTANEOUS COMPLEX FILTER RETRIEVAL ON (B)(6) 2020. PER COMPUTED TOMOGRAPHY REPORT, "POSITIVE FOR CAVAL PERFORATION. SUPERIOR EXTENT OF IVC FILTER INFERIOR L2 VERTEBRAL BODY. INFERIOR EXTENT L3-L4 DISC SPACE. A TOTAL OF 4 PRONGS HAVE PERFORATED THROUGH IVC..." "MAXIMUM DISTANCE PRONGS PERFORATED THROUGH IVC 7.07 MM..." "CORONAL IMAGES 3.24 DEGREE TILT RIGHT TO LEFT..." "SAGITTAL IMAGES 12.12 DEGREE TILT ANTERIOR POSTERIOR..." "DIAMETER OF IVC DIRECTLY ABOVE FILTER 24.11 MM X 16.40 MM..." "PRONGS HAVE PERFORATED BOTH AORTA AND DUODENUM..." PER RETRIEVAL REPORT, "SUCCESSFUL IVC FILTER REMOVAL. IVC FILTER MIGRATED TO THE RIGHT ATRIUM DURING ATTEMPTED RETRIEVAL, SUCCESSFULLY CAPTURED. FRACTURE OF EN SNARE FRAGMENT DURING IVC FILTER RETRIEVAL, WHICH MIGRATED TO THE RIGHT VENTRICLE AND SUBSEQUENTLY TO A SEGMENTAL BRANCH TO LEFT MAIN PULMONARY ARTERY. FRAGMENT SUCCESSFULLY RETRIEVED".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1696378 | GUNTHER TULIP JUGULAR VENA CAVA FILTER SET | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | COOK INC | G33017 | 3323510 | 10827002330174 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Life Threatening |