COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET
Report
- Report Number
- 3002808486-2022-00354
- Event Type
- Injury
- Date Received
- May 19, 2022
- Report Date
- September 14, 2022
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- UDI-DI
- 10827002345024
- 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 FRACTURE HAS BEEN REPORTED AND MAY BE EITHER SYMPTOMATIC OR ASYMPTOMATIC. FRACTURE OF A FILTER LEG MAY BE DUE TO REPETITIVE MOTION ON A FILTER LEG IN AN UNUSUAL, STRESSED POSITION, SUCH AS A FILTER LEG PENETRATING/PERFORATING THE IVC; OR A FILTER LEG BEING CAUGHT IN A SIDE BRANCH (E.G., A RENAL VEIN). OTHER POTENTIAL CAUSES OF FILTER FRACTURE MAY INCLUDE EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IMPLANTED FILTER (E.G., A SURGICAL OR ENDOVASCULAR PROCEDURE IN THE VICINITY OF A FILTER). RETRIEVAL OF A FRACTURED FILTER OR FILTER FRAGMENTS (INCLUDING EMBOLIZED FRAGMENTS) USING ENDOVASCULAR TECHNIQUES HAS BEEN REPORTED. POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: FILTER FRACTURE, FILTER OR FILTER FRAGMENT EMBOLIZATION, TRAUMA TO ADJACENT STRUCTURES. TO DATE, NO OTHER COMPLAINTS HAVE BEEN REPORTED AGAINST THIS LOT. THE DEVICE IS MANUFACTURED AND INSPECTED ACCORDING TO CURRENT CONTROLS. TO DATE, NO OTHER COMPLAINTS HAVE BEEN REPORTED AGAINST THIS LOT. 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: THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: FRACTURE, VENA CAVA (VC) PERFORATION, MIGRATION, TILT, ANXIETY, WORRY, FEAR, LIMITED ACTIVITY. INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. THE REPORTED ALLEGATIONS HAVE BEEN FURTHER INVESTIGATED BASED ON THE INFORMATION PROVIDED TO DATE. FILTER FRACTURE HAS BEEN REPORTED AND MAY BE EITHER SYMPTOMATIC OR ASYMPTOMATIC. FRACTURE OF A FILTER LEG MAY BE DUE TO REPETITIVE MOTION ON A FILTER LEG IN AN UNUSUAL, STRESSED POSITION, SUCH AS A FILTER LEG PENETRATING/PERFORATING THE IVC; OR A FILTER LEG BEING CAUGHT IN A SIDE BRANCH (E.G., A RENAL VEIN). OTHER POTENTIAL CAUSES OF FILTER FRACTURE MAY INCLUDE EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IMPLANTED FILTER (E.G., A SURGICAL OR ENDOVASCULAR PROCEDURE IN THE VICINITY OF A FILTER). RETRIEVAL OF A FRACTURED FILTER OR FILTER FRAGMENTS (INCLUDING EMBOLIZED FRAGMENTS) USING ENDOVASCULAR TECHNIQUES HAS BEEN REPORTED. POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: FILTER FRACTURE, FILTER OR FILTER FRAGMENT EMBOLIZATION, TRAUMA TO ADJACENT STRUCTURES. 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: VASCULAR TRAUMA, VENA CAVA PERFORATION, VENA CAVA PENETRATION. 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. 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. UNKNOWN IF THE REPORTED ANXIETY, WORRY, FEAR, AND LIMITED ACTIVITY DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. 20 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 FRACTURE. HOSPITAL AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED."
PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2016 VIA THE RIGHT FEMORAL VEIN DUE TO DEEP VEIN THROMBOSIS (DVT). THE PATIENT ALLEGES VENA CAVA PERFORATION AND PERFORATION TO ABUT DUODENUM. THE PATIENT FURTHER ALLEGES ANXIETY, WORRY, FEAR, AND LIMITED ACTIVITY. ON 07JUL2020, PER A REPORT FROM COMPUTED TOMOGRAPHY; ¿CAVAL PERFORATION: YES. GRADE 3 PERFORATIONS OF '891011121' AND 2 O¿CLOCK LEGS TO ABUT DUODENUM. GRADE 2 PERFORATION 7 O¿CLOCK LEG 1.27 CM. TILT: YES. 13.27 DEGREES OF SAGITTAL TILT. APEX OF FILTER DOES NOT TOUCH WALL OF IVC. MIGRATION: YES. APEX OF FILTER 1.0 CM ABOVE THE LEFT RENAL VEIN CONFLUENCE. PERTINENT NEGATIVES: NO IVC STENOSIS. ADDITIONAL FINDINGS: APPEARANCE SUGGESTS FRACTURE OR MISSING STRUT AT 4 O¿CLOCK.¿
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2230527 | COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE | G34502 | E3388440 | 10827002345024 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Life Threatening |