COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
Report
- Report Number
- 3002808486-2017-00171
- Event Type
- Injury
- Date Received
- January 30, 2017
- Date of Event
- October 7, 2016
- Report Date
- January 11, 2019
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- UDI-DI
- 10827002345048
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. INVESTIGATION STILL IN PROGRESS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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.
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURER REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. SUMMARY OF INVESTIGATIONAL FINDINGS: THE MANUFACTURER'S DEVICE ANALYSIS RESULTS. COMPLAINT REOPENED DUE TO RECEIPT OF TWO YEARS FOLLOW UP IMAGING. INVESTIGATION IS BASED ON EVENT DESCRIPTION AND IMAGE REVIEW. AT TWO YEARS FOLLOW UP THERE WERE 11 LEGS WITH GRADE 1 FILTER LEG INTERACTION AND 1 LEG WITH GRADE 2 FILTER LEG INTERACTION. NO HARM TO PATIENT REPORTED. FOLLOW-UP CT SCAN PERFORMED 2 YEARS AFTER PLACEMENT, CONTINUES TO DEMONSTRATE THE CELECT PLATINUM IVC FILTER IN RELATIVELY STABLE POSITION WHEN COMPARED TO THE PREVIOUS CT SCAN. THERE IS NO SIGNIFICANT CHANGE IN TILT OR INTERACTIONS WITH THE 10 PRIMARY AND SECONDARY FILTER LEGS WHICH PREVIOUSLY DEMONSTRATED GRADE 1 INTERACTIONS. THE GRADE 2 INTERACTION INVOLVING THE PRIMARY FILTER LEG AT THE 9:00 REGION IS ALSO UNCHANGED. THE PRIMARY FILTER LEG AT THE 12:00 REGION NOW DEMONSTRATES A GRADE 2 INTERACTION, WHERE IT PREVIOUSLY DEMONSTRATED A GRADE 3 INTERACTION WITH THE WALL OF THE IVC AND THE RENAL COLLECTING SYSTEM. ON THE CT SCAN THE RENAL COLLECTING SYSTEM IS LESS DISTENDED AND IS SLIGHTLY RETRACTED, THEREFORE NO LONGER ABUTS THE FILTER FOOT AS IT DID ON THE PREVIOUS CT SCAN. AGAIN, THIS CHANGE IN INTERACTION IS DUE TO THE PATIENT'S UNDERLYING ANATOMY AND THE EXTENSION OF THE PRIMARY FILTER LEG THROUGH THE ANTERIOR WALL OF THE IVC HAS NOT SIGNIFICANTLY CHANGED IN THE INTERIM. VENA CAVA WALL PERFORATION IS A KNOWN POTENTIAL COMPLICATION OF VENA CAVA FILTERS. BOTH SYMPTOMATIC AND ASYMPTOMATIC EVENTS HAVE BEEN REPORTED. AMONG OTHER CAUSES, VENA CAVA WALL PERFORATION MAY INADVERTENTLY BE INITIATED BY IMPROPER DEPLOYMENT, EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IMPLANTED FILTER (E.G., A SURGICAL PROCEDURE IN THE VICINITY OF A FILTER) AND (OR) PROCEDURES THAT INVOLVE OTHER DEVICES BEING PASSED THROUGH AN IN SITU FILTER. STILL THERE IS 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 MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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.
EXEMPTION NUMBER E2016032. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: REINVESTIGATION IS BASED ON EVENT DESCRIPTION AND IMAGE REVIEW OF PROVIDED TWELVE MONTHS FU IMAGING. TWELVE MONTH FOLLOW-UP CT DEMONSTRATES PERSISTENT ABNORMAL CONFIGURATION OF THE PATIENT'S INFERIOR VENA CAVA DUE TO A SEVERE ROTATORY SCOLIOSIS OF THE LUMBAR SPINE. THIS ABNORMAL CONFIGURATION RESULTS IN AN ATYPICAL CONFIGURATION OF THE IVC FILTER RELATIVE TO THE BONY LANDMARKS. HOWEVER, WHEN THE IVC FILTER IS EVALUATED RELATIVE TO THE CENTER LINE OF THE IVC, THERE IS NO EVIDENCE OF SIGNIFICANT TILT. DESPITE THIS, THERE WAS INTERVAL DEVELOPMENT OF A GRADE 3 INTERACTION INVOLVING THE PRIMARY FILTER LEG PENETRATING THROUGH THE WALL OF THE IVC AND ABUTTING THE RIGHT RENAL PELVIS. THE RIGHT KIDNEY IS IN THE ABNORMAL LOCATION, ALSO DUE TO THE SCOLIOSIS, AND IS LOCATED ANTERIOR TO THE IVC AND LIKELY RESULTS IN EXTRINSIC COMPRESSION OF THE IVC. THERE ALSO WAS INTERVAL DEVELOPMENT OF A GRADE 2 INTERACTION INVOLVING A SECOND PRIMARY FILTER LEG. ALTHOUGH THE EXACT CAUSE OF THE PENETRATIONS IS INDETERMINATE, THEY WERE LIKELY ACCENTUATED DUE TO THE ABNORMAL CONFIGURATION OF THE IVC FROM THE ROTATORY SCOLIOSIS AS WELL AS THE EXTRINSIC COMPRESSION ON THE IVC DUE TO THE ABNORMALLY LOCATED RIGHT KIDNEY. VENA CAVA WALL PERFORATION IS A KNOWN POTENTIAL COMPLICATION OF VENA CAVA FILTERS. BOTH SYMPTOMATIC AND ASYMPTOMATIC EVENTS HAVE BEEN REPORTED. AMONG OTHER CAUSES, VENA CAVA WALL PERFORATION MAY INADVERTENTLY BE INITIATED BY IMPROPER DEPLOYMENT, EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IMPLANTED FILTER (E.G., A SURGICAL PROCEDURE IN THE VICINITY OF A FILTER) AND (OR) PROCEDURES THAT INVOLVE OTHER DEVICES BEING PASSED THROUGH AN IN SITU FILTER. 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 MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.
ADDITIONAL INFORMATION RECEIVED 09OCT2018: FROM THE CT SCAN PERFORMED ON (B)(6) 2017, THE LAB REVIEW REVEALED 12 FILTER LEGS WITH GRADE 2 FILTER LEG INTERACTION, NO HEMORRHAGE, HEMATOMA, OR OTHER CLINICAL FINDINGS WERE OBSERVED AT THE PERFORATION/PUNCTURE SITE. ON (B)(6) 2018 (707 DAYS POST-PROCEDURE), A FOLLOW-UP ABDOMINAL CT SCAN WAS PERFORMED. PER THE SITE THE HIGHEST-GRADE FILTER LEG INTERACTION WITH THE IVC WAS GRADE 1. PER LAB REVIEW THERE WAS NO EVIDENCE OF FILTER EMBOLIZATION, THERE WERE 11 LEGS WITH GRADE 1 FILTER LEG INTERACTION AND 1 LEG WITH GRADE 2 FILTER LEG INTERACTION. THERE WAS NO HEMORRHAGE, HEMATOMA, OR OTHER CLINICAL FINDINGS OBSERVED AT THE PERFORATION PUNCTURE SITE.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
EXEMPTION NUMBER E2016032. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: INVESTIGATION IS BASED ON IMAGE REVIEW. POST-DEPLOYMENT VENOGRAM DEMONSTRATED INSIGNIFICANT TILT IN REFERENCE TO THE SEGMENT OF IVC, BUT A 19 DGR TILT FROM THE BONY LANDMARKS. HOWEVER, THIS DISCREPANCY WAS DUE TO SEVERE ROTATORY SCOLIOSIS AND MAY-THURNER ANATOMY WITH DISTORTION OF THE NORMAL STRAIGHT COURSE OF THE IVC. THE FILTER WAS PLACED PRIOR TO SPINE SURGERY, SO THE DISTORTED ANATOMY MAY BE ALTERED DURING SAID PROCEDURE AND CAN RESULT IN A CHANGE IN THE FILTER POSITION AND/OR RESULT IN DIFFICULTY AND POTENTIAL FUTURE RETRIEVAL. FILTER TILT IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE AND MAY OCCUR DURING PLACEMENT OR DURING IMPLANTING PERIOD. 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 MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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. EXEMPTION NUMBER E2016032. (B)(4). MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: INVESTIGATION IS BASED ON IMAGE REVIEW. POST-DEPLOYMENT VENOGRAM DEMONSTRATED INSIGNIFICANT TILT IN REFERENCE TO THE SEGMENT OF IVC, BUT A 19 DGR TILT FROM THE BONY LANDMARKS. HOWEVER, THIS DISCREPANCY WAS DUE TO SEVERE ROTATORY SCOLIOSIS AND MAY-THURNER ANATOMY WITH DISTORTION OF THE NORMAL STRAIGHT COURSE OF THE IVC. THE FILTER WAS PLACED PRIOR TO SPINE SURGERY, SO THE DISTORTED ANATOMY MAY BE ALTERED DURING SAID PROCEDURE AND CAN RESULT IN A CHANGE IN THE FILTER POSITION AND/OR RESULT IN DIFFICULTY AND POTENTIAL FUTURE RETRIEVAL. FILTER TILT IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE AND MAY OCCUR DURING PLACEMENT OR DURING IMPLANTING PERIOD. 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 MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.
(B)(4). CATALOG#: IGTCFS-65-2-UNI-CELECT-PT. SIMILAR TO DEVICE UNDER 510(K) K121629. (B)(4). INVESTIGATION IS STILL IN PROGRESS.
EXEMPTION NUMBER E2016032. (B)(4). NAME AND ADDRESS FOR IMPORTER SITE: (B)(4). INVESTIGATION IS STILL IN PROGRESS.
DESCRIPTION OF EVENT ACCORDING TO STUDY: AT THE INDEX PROCEDURE ON (B)(6) 2016 THE PATIENT RECEIVED A CELECT FILTER. THE INFERIOR VENA CAVA (IVC) DIAMETER AT THE INTENDED FILTER LOCATION WAS 29 MM. THE IVC WAS NOTED TO HAVE AN ANOMALY, CURVED AS SEVERE SCOLIOSIS. THERE WAS NO THROMBUS IN THE IVC PRIOR TO FILTER PLACEMENT. USING THE RIGHT COMMON FEMORAL VEIN AS THE ACCESS SITE, A CELECT® FILTER WAS DEPLOYED AT THE INTENDED LOCATION IN THE IVC INFRARENAL SITE AND IN A LOCATION SUITABLE TO PROVIDE SUFFICIENT MECHANICAL PROTECTION AGAINST PE. THE FILTER NEITHER DEPLOYED PREMATURELY NOR DID THE FILTER JUMP UPON DEPLOYMENT. THERE WAS NO EVIDENCE OF FILTER FRACTURE, DEFORMATION, OR MIGRATION. FILTER TILT WAS REPORTED AS 0 DEGREES BY SITE. THERE WAS NO EXTRAVASATION OF CONTRAST OR FILTER LEGS APPEARING OUTSIDE THE COLUMN OF CONTRAST AFTER PLACEMENT. ANALYSIS OF THE PLACEMENT PROCEDURE VENACAVAGRAM REVEALED A SUB-OPTIMAL IMAGE. THERE WAS NO IVC ANOMALY NOTED OR THROMBUS IN THE IVC PRIOR TO FILTER PLACEMENT. THE IVC DIAMETER WAS UNABLE TO BE ASSESSED. THE FILTER WAS PLACED IN THE IVC INFRARENAL SITE. THERE WAS NO EVIDENCE OF FILTER DEFORMATION OR MIGRATION WITH FILTER TILT OF 2.2 DEGREES IN THE AP VIEW. THERE WAS NO EXTRAVASATION OF CONTRAST BUT FILTER LEGS DID APPEAR OUTSIDE THE COLUMN OF CONTRAST AFTER PLACEMENT. THE POST-PROCEDURE X-RAY COMPLETED THE SAME DAY REVEALED NO EVIDENCE OF FILTER FRACTURE, EMBOLIZATION, MIGRATION, WITH 0 DEGREES FILTER TILT PER THE SITE. ANALYSIS REVEALED NO FILTER FRACTURE, DEFORMATION, OR EMBOLIZATION. THERE WAS 17.4 DEGREES OF FILTER TILT IN THE AP VIEW AND 9.8 DEGREES OF FILTER TILT IN THE LAT VIEW. PATIENT OUTCOME: THE PATIENT REMAINS IN THE STUDY.
ADDITIONAL INFORMATION RECEIVED 15NOV2017: ON (B)(6) 2017, THE THREE-MONTH FOLLOW-UP CLINICAL ASSESSMENT WAS COMPLETED AND A RETRIEVAL OF THE FILTER WAS NOT SCHEDULED BECAUSE THE PATIENT WAS UNWILLING TO UNDERGO RETRIEVAL. ON (B)(6) 2017, THE SIX-MONTH FOLLOW-UP TELEPHONE CALL WAS COMPLETED. ON (B)(6) 2017, THE 12-MONTH FOLLOW-UP CLINICAL ASSESSMENT, CT OF THE ABDOMEN AND PELVIC WITH INTRAVENOUS CONTRAST, X-RAY, AND ULTRASOUND WERE COMPLETED. THE FILTER WAS NOT SCHEDULED TO BE RETRIEVED. THE CT REVEALED NO EVIDENCE OF FILTER EMBOLIZATION AND A GRADE 1 FILTER LEG INTERACTION WITH THE IVC WALL. THE ULTRASOUND REVEALED NO EVIDENCE OF THROMBUS IN THE IVC, PELVIC VEINS, OR LOWER EXTREMITY VEINS. THE X-RAY REVEALED NO EVIDENCE OF FILTER FRACTURE, EMBOLIZATION, TILT, OR MIGRATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 68892 | COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE | E3467141 | 10827002345048 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Life Threatening |