GUNTHER TULIP FEMORAL VENA CAVA FILTER SET
Report
- Report Number
- 1820334-2017-00971
- Event Type
- Malfunction
- Date Received
- May 11, 2017
- Date of Event
- April 26, 2012
- Report Date
- November 30, 2018
- Manufacturer
- COOK INC
- Product Code
- DTK
- PMA / PMN Number
- K043509
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- ATTORNEY
Narratives
WILLIAM COOK EUROPE INITIALLY REPORTED EVENT UNDER MFR REPORT # 3002808486-2016-00751. NEW INFORMATION WAS RECEIVED IDENTIFYING THAT THE PRODUCT WAS A COOK INC. MANUFACTURED DEVICE. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.
CORRECTION: A RETROSPECTIVE REVIEW OF RECORDS PERFORMED ON (B)(6) 2018 DISCOVERED THAT FOLLOW UP 2 MDR 1820334-2016-00971 WAS SENT INSTEAD OF FOLLOW UP 1 MDR 1820334-2017-00971. FOLLOW UP 1 MDR 1820334-2017-00971 HAS BEEN CREATED AS TO A CORRECTION TO REPORT THE EVALUATION RESULTS. INVESTIGATION EVALUATION: IT HAS NOT BEEN POSSIBLE TO FURTHER INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE VIA THE OPERATIVE NOTE STATING "PLAINTIFF IS ALLEGING DEVICE IS UNABLE TO BE RETRIEVED, EMBEDDED, DVT, RLE SWELLING, TIRED¿. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED. UNKNOWN IF THE REPORTED ¿DVT, RLE SWELLING, TIRED¿ IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. 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. 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.
INVESTIGATION - EVALUATION: INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. IT HAS NOT BEEN POSSIBLE TO FURTHER INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE VIA THE OPERATIVE NOTE STATING "PLAINTIFF IS ALLEGING DEVICE IS UNABLE TO BE RETRIEVED, EMBEDDED, DEEP VEIN THROMBOSIS, RLE SWELLING, TIRED¿. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED. UNKNOWN IF THE REPORTED ¿DEEP VEIN THROMBOSIS, RLE SWELLING, TIRED¿ IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. 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. NO RELEVANT NOTES FOUND ON WORK ORDER OR DEVICE LOT. NO OTHER COMPLAINTS ON LOT. 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.
THIS CORRECTED MDR# 1820334-2017-00971 FOLLOW UP 2 IS BEING SUBMITTED TO FILL THE GAP BETWEEN FOLLOW UP 1 AND 3 AS REQUESTED BY FDA CONSUMER SAFETY OFFICER. (B)(4). INVESTIGATION EVALUATION: IT HAS NOT BEEN POSSIBLE TO FURTHER INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE VIA THE OPERATIVE NOTE STATING "PLAINTIFF IS ALLEGING DEVICE IS UNABLE TO BE RETRIEVED, EMBEDDED, DVT, RLE SWELLING, TIRED¿. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED. UNKNOWN IF THE REPORTED ¿DVT, RLE SWELLING, TIRED¿ IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. 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. 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.
PLAINTIFF ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2010 VIA THE RIGHT COMMON FEMORAL VEIN DUE TO RIGHT LOWER EXTREMITY DVT AND PULMONARY EMBOLISM. PATIENT REPORTS TO BE EXPERIENCING DVT, RLE SWELLING, TIRED. PLAINTIFF ALLEGES ATTEMPTED RETRIEVAL ON (B)(6) 2012. PLAINTIFF IS ALLEGING DEVICE IS EMBEDDED AND IS UNABLE TO BE RETRIEVED.
NO ADDITIONAL INFORMATION PROVIDED AT THIS TIME.
NO ADDITIONAL INFORMATION PROVIDED AT THIS TIME.
PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2010 VIA THE RIGHT COMMON FEMORAL VEIN DUE TO RIGHT LOWER EXTREMITY DVT AND PULMONARY EMBOLISM. PATIENT IS ALLEGING DEVICE IS UNABLE TO BE RETRIEVED, EMBEDDED, DVT. PATIENT FURTHER ALLEGES "TIRE EASY, LACK OF MOTIVATION. AFRAID TO EXERT MYSELF, MAY CAUSE FILTER TO MOVE. SWELLING OF LEG." AN ATTEMPTED RETRIEVAL WAS PERFORMED ON (B)(6) 2012 BUT WAS REPORTED TO BE UNSUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 342051 | GUNTHER TULIP FEMORAL VENA CAVA FILTER SET | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | COOK INC | 2360266 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR |