UNKNOWN
Report
- Report Number
- 1820334-2022-00927
- Event Type
- Injury
- Date Received
- May 19, 2022
- Report Date
- September 15, 2022
- Manufacturer
- COOK INC
- Product Code
- DTK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
CUSTOMER (PERSON) NOT PROVIDED, INFORMATION PROVIDED BY ONDERLAW, LLC. OCCUPATION: NON-HEALTHCARE PROFESSIONAL. INVESTIGATION: NEW PE AS A REPORTED COMPLICATION, IS A KNOWN RISK IN RELATION TO FILTER IMPLANT AND IS WELL DOCUMENTED IN THE CLINICAL LITERATURE AND IN CLINICAL PRACTICE GUIDELINES. THIS IS SUPPORTED BY THE CLINICAL EVIDENCE REPORT ESTABLISHED TO ASSESS AVAILABLE CLINICAL DATA TO IDENTIFY AND EVALUATE THE CLINICAL SAFETY AND PERFORMANCE OF THE COOK VENA CAVA FILTERS. POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: PULMONARY EMBOLISM. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. CORRECTED INFORMATION: ANNEX A ROW #1 - CORRECTED FROM A0512 - UNINTENDED MOVEMENT TO A140401 -INADEQUATE FILTRATION PROCESS. ADDITIONAL INFORMATION: A4, B2, B5, B6, B7, H6 (PATIENT AND DEVICE CODES). INVESTIGATION: IT WAS REPORTED TO COOK THAT A PATIENT RECEIVED AN UNKNOWN BIRD¿S NEST FILTER, BNF-, FROM AN UNKNOWN LOT, AND IS ALLEGING VENA CAVA PERFORATION, ANTICOAGULATION AND OCCLUSION, AND MULTIPLE CHRONIC DEEP VEIN THROMBOSIS (DVT). THIS INCIDENT WAS REPORTED BY ONDERLAW, LLC, IN THE UNITED STATES, ON (B)(6) 2022. A DEVICE MASTER RECORD (DMR) REVIEW WAS PERFORMED, AND DEVICE DRAWINGS, SPECIFICATIONS, AND QUALITY CONTROL PROCEDURES ASSOCIATED WITH THE COMPLAINT WERE IDENTIFIED. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. DUE TO NO LOT NUMBER BEING PROVIDED, A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE COMPLETED. THE DEVICE'S DESIGN HISTORY FILES (DHF) WERE REVIEWED, AND THE RISKS ASSOCIATED WITH THESE DEVICES ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. AT THIS TIME, A DEVICE FAILURE ANALYSIS COULD NOT BE COMPLETED. THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, DHF, AND IFU, SUGGEST THAT THERE IS NO EVIDENCE THE DEVICE WAS NOT MANUFACTURED TO SPECIFICATION, OR THAT THERE ARE NONCONFORMING DEVICES IN HOUSE OR OUT IN THE FIELD. THE PRODUCT IFU, [T_FEMBNF_REV3] ¿GIANTURCO-ROEHM BIRD¿S NEST VENA CAVA FILTER FOR FEMORAL PLACEMENT,¿ AND [T_JUGBNF_REV3] ¿GIANTURCO-ROEHM BIRD¿S NEST VENA CAVA FILTER FOR JUGULAR PLACEMENT¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: ¿POTENTIAL ADVERSE EVENTS INCLUDE, BUT ARE NOT LIMITED TO: FILTER MIGRATION (MAY OCCUR IF PROPER ANCHORING TECHNIQUES ARE NOT UTILIZED) INFERIOR VENA CAVA THROMBOSIS. PERFORATION OF VENA CAVA WALL. HEMATOMA AT PUNCTURE SITE¿. THE COMPLAINT WAS CONFIRMED BASED ON CUSTOMER TESTIMONY. COOK COULD NOT CONCLUDE A CAUSE OF FAILURE AT THIS TIME. THE RISK ANALYSIS FOR THE FAILURE MODE WAS REVIEWED AND IT WAS DETERMINED THAT NO ESCALATION ACTIONS WERE REQUIRED. THE APPROPRIATE PERSONNEL WILL BE NOTIFIED, AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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 AND H6. ADDITIONAL INFORMATION: INVESTIGATION. DEVICE HISTORY RECORD (DHR) REVIEW: THE CUSTOMER DID NOT PROVIDE A LOT NUMBER FOR THIS COMPLAINT. DUE TO THIS, COOK COULD NOT COMPLETE A REVIEW OF THE DHR. CURRENTLY, THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. DEVICE FAILURE ANALYSIS: THE COMPLAINANT DID NOT RETURN THE COMPLAINT DEVICE TO COOK FOR INVESTIGATION. AT THIS TIME, NO VISUAL, DIMENSIONAL, OR FUNCTIONAL VERIFICATIONS COULD BE COMPLETED. COOK COULD NOT CONCLUDE THAT THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. CONCLUSION: A DEFINITIVE CONCLUSION COULD NOT BE DETERMINED. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED AND NO ADDITIONAL ESCALATION WAS REQUIRED. A DEVICE MASTER RECORD (DMR) REVIEW WAS PERFORMED, AND DEVICE DRAWINGS, SPECIFICATIONS, AND QUALITY CONTROL PROCEDURES ASSOCIATED WITH THE COMPLAINT WERE IDENTIFIED. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. DUE TO NO LOT NUMBER BEING PROVIDED, A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE COMPLETED. THE DEVICE'S DESIGN HISTORY FILES (DHF) WERE REVIEWED, AND THE RISKS ASSOCIATED WITH THESE DEVICES ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, DHF, AND IFU, SUGGEST THAT THERE IS NO EVIDENCE THE DEVICE WAS NOT MANUFACTURED TO SPECIFICATION, OR THAT THERE ARE NONCONFORMING DEVICES IN HOUSE OR OUT IN THE FIELD. THE COMPLAINT WAS CONFIRMED BASED ON CUSTOMER TESTIMONY. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THE RISK ANALYSIS FOR THE FAILURE MODE WAS REVIEWED AND IT WAS DETERMINED THAT NO ESCALATION ACTIONS WERE REQUIRED. THE APPROPRIATE PERSONNEL WILL BE NOTIFIED, AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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 BIRD'S NEST (BNF) FILTER. PATIENT IS ALLEGING PE. HOSPITAL AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED."
PATIENT ALLEGEDLY RECEIVED A BIRDS NEST FILTER DUE TO BLOOD CLOTS. PATIENT IS ALLEGING VENA CAVA PERFORATION, REQUIRES ANTICOAGULATION, OCCLUSION, AND MULTIPLE CHRONIC DEEP VEIN THROMBOSIS (DVT). PATIENT NOTES AND FURTHER ALLEGES EXPERIENCING PAIN FROM MULTIPLE BLOOD CLOTS, LIMITED MOBILITY, HOSPITALIZED MANY TIMES FOR DVTS POST FILTER PLACEMENT; OCCLUDED FILTER. PER A VENOGRAM: "A QUICK-CROSS WAS PLACED UP INTO THE INFERIOR VENA CAVA. IT WAS OPEN ABOVE. WE SHOT VENOGRAMS OF THE ILIAC AND FEMORAL AND NOTED STILL COMPLETE OCCLUSION. WE THEN BALLOON VENOPLASTIED THE AREA THROUGH THE INFERIOR VENA CAVA FILTER AND THE ILIAC VEIN. WE WERE ABLE TO GET SOME INLINE FLOW FROM THE COMMON FEMORAL UP THROUGH THE INFERIOR VENA CAVA". "VENOGRAPHIC FINDINGS: 1. THERE WAS MORE COLLATERAL FLOW NOTED IN THE LOWER LEG WITH POTENTIAL CLOT REMOVED FROM THE COLLATERALS. 2. AFTER TREATMENT, THERE WAS SOME FLOW THROUGH THE INFERIOR VENA CAVA AND ILIAC VEIN". PER A VENOGRAM: "I WENT UP WITH A 6 X 200 BALLOON AND PERFORMED ILIAC INTERVENTION AS WELL AS FEMORAL INTERVENTION TO TRY TO ESTABLISH SOME TYPE OF INLINE FLOW THROUGH TO THE INFERIOR VENA CAVA". "VENOGRAPHIC FINDINGS: THERE WAS SOME FLOW THROUGH THE INFERIOR VENA CAVA FILTER BUT IT WAS HEAVILY DISEASED WITH CHRONIC OCCLUSION. THE FEMORAL VEINS WERE THE SAME AS ABOVE. INTRAVASCULAR ULTRASOUND FINDINGS: THERE WAS NORMAL FLOW ABOVE THE INFERIOR VENA CAVA FILTER". "THE COMMON FEMORAL WAS COMPLETELY OCCLUDED ON INTRAVASCULAR ULTRASOUND". "THE POPLITEAL JUST ABOVE THE KNEE WAS OCCLUDED AS WELL".
NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1190633 | UNKNOWN | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | COOK INC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Hospitalization| R| L |