GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET
Report
- Report Number
- 3002808486-2022-00629
- Event Type
- Injury
- Date Received
- May 19, 2022
- Report Date
- February 21, 2023
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- UDI-DI
- 10827002529172
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
CUSTOMER (PERSON) NOT PROVIDED, INFORMATION PROVIDED BY DALIMONTE RUEB STOLLER LLP. OCCUPATION: NON-HEALTHCARE PROFESSIONAL. 510(K) #: K211875. INVESTIGATION: 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. RPN/LOT IS UNKNOWN, HOWEVER, THE DEVICE IS MANUFACTURED AND INSPECTED ACCORDING TO CURRENT CONTROLS. 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. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.
INVESTIGATION: INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: EMBEDDED, UNABLE TO RETRIEVE, ANXIETY, WORRY, DEPRESSION, FEAR, LIMITED PHYSICAL ACTIVITY, PAIN. THE REPORTED ALLEGATIONS HAVE BEEN FURTHER INVESTIGATED BASED ON THE INFORMATION PROVIDED TO DATE. THE ADDITIONAL INFORMATION REGARDING EMBEDDED DOES NOT CHANGE THE PREVIOUS INVESTIGATION RESULTS FOR ORGAN/VENA CAVA PERFORATION. 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). 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. UNKNOWN IF THE REPORTED ANXIETY, WORRY, DEPRESSION, FEAR, LIMITED PHYSICAL ACTIVITY, PAIN IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. (B)(4) DEVICES IN LOT. ONE OTHER COMPLAINT HAS BEEN REPORTED AGAINST THE LOT FOR A SIMILAR ISSUE. 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 REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. THE FOLLOWING FIELDS WERE UPDATED PER ADDITIONAL INFORMATION RECEIVED: B5, H6. G4: K211874. INVESTIGATION THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: ORGAN/VENA CAVA PERFORATION, TILT. INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. THE REPORTED ALLEGATIONS HAVE BEEN FURTHER INVESTIGATED BASED ON THE INFORMATION PROVIDED TO DATE. 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. FILTER TILT HAS BEEN REPORTED. POTENTIAL CAUSES MAY INCLUDE FILTER PLACEMENT IN IVCS WITH DIAMETERS LARGER THAN THOSE SPECIFIED IN THESE INSTRUCTIONS FOR USE; IMPROPER DEPLOYMENT; MANIPULATIONS NEAR AN IMPLANTED FILTER (E.G., A SURGICAL OR ENDOVASCULAR PROCEDURE IN THE VICINITY OF A FILTER); AND (OR) A FAILED RETRIEVAL ATTEMPT. EXCESSIVE FILTER TILT MAY CONTRIBUTE TO DIFFICULT OR FAILED RETRIEVAL; VENA CAVA WALL PENETRATION/PERFORATION; AND (OR) RESULT IN LOSS OF FILTER EFFICIENCY. POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: UNACCEPTABLE FILTER TILT. (B)(4) DEVICES IN LOT. NO RELEVANT NOTES ON WORK ORDER. THE PRODUCT 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 BECOMES AVAILABLE. 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.
IT IS ALLEGED THAT "PATIENT RECEIVED A COOK CELECT PLATINUM FILTER. PATIENT IS ALLEGING PERFORATION OF ORGAN. HOSPITAL AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED."
PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2016 VIA THE RIGHT COMMON FEMORAL VEIN DUE TO FACTOR V LEIDEN. PATIENT IS ALLEGING ORGAN AND VENA CAVA PERFORATION, TILT, AND FAILED RETRIEVAL ATTEMPT ON (B)(6) 2021. PATIENT ALLEGES "MULTIPLE PRONGS OF THE IVC FILTER IMPLANTED IN MY BODY HAVE PERFORATED THROUGH MY IVC. ONE PRONG OF THE FILTER IS PERFORATING MY L3 VERTEBRAL BODY. FURTHER, THE FILTER HAS ALSO TILTED SUBSTANTIALLY. I LIVE WITH THE ANXIETY OF HAVING A FILTER THAT COULD FAIL FURTHER AT ANY TIME, BUT THAT CANNOT BE RETRIEVED WITHOUT A SERIOUS SURGERY, DESPITE A PREVIOUS FAILED ATTEMPT. I AM WORRIED BECAUSE MY FILTER HAS TILTED WITHIN MY VENA CAVA AND PERFORATED OUTSIDE OF IT INTO OTHER ORGANS, CAUSING PAIN." "FOR FEAR OF AGGRAVATING MY CURRENT CONDITION AND CAUSING POTENTIAL FUTURE INJURIES RELATED TO THE COOK GUNTHER TULIP FILTER IMPLANTATION, I TRY NOT TO ENGAGE IN ANY ACTIVITIES THAT CAUSE ME TO EXERT MYSELF." DEPRESSION, ANXIETY, PAIN PER COMPUTED TOMOGRAPHY REPORT, "CAVAL PERFORATION: YES. 7 O'CLOCK 3.80 MM GRADE 4 EXTENDING INTO THE L3 VERTEBRAL BODY. 1 O'CLOCK 4.10 MM GRADE 2. 10 O'CLOCK 3.70 MM GRADE 2." "TILT: YES. POSTERIOR MEASURING 17.03 DEGREES. LIFT-SIDED TILT MEASURING 8.27 DEGREES." PER RETRIEVAL (ATTEMPTED) REPORT, "I ATTEMPTED TO SNARE THE HOOK OF THE FILTER FROM THE INTERNAL JUGULAR VEIN BUT WAS UNSUCCESSFUL. AFTER MULTIPLE ORTHOGONAL VIEWS IT APPEARED THAT THE FILTER WAS STUCK IN THE WALL. I WORKED THE WIRE THROUGH THE RIGHT GROIN WITH USE OF A CATHETER TO WHAT APPEARED TO BE BEHIND THE LEVEL OF THE HOOK. I THEN ATTEMPTED TO BALLOON THE FILTER OFF THE IVC WALL AND RESNARED, DESPITE THIS I WAS UNABLE TO GET A GRASP OF ANY PART OF THE FILTER TO TRY AND RETRIEVE IT. EVENTUALLY WE ABORTED AND SHE WILL LIKELY NEED A FORCEPS REMOVAL AT A CENTER THAT SPECIALIZES IN THESE." "RETRIEVAL HOOK IMBEDDED IN IVC WALL"
ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT WAS IMPLANTED WITH A TULIP FILTER. THE PATIENT ALLEGES MULTIPLE PRONGS OF THE INFERIOR VENA CAVA (IVC) FILTER PERFORATE THE IVC, ONE PRONG PERFORATES THE L3 VERTEBRAL BODY, AND TILT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2319933 | GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE | G52917 | E3313547 | 10827002529172 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Life Threatening |