UNKNOWN
Report
- Report Number
- 3002808486-2015-00136
- Date Received
- October 27, 2015
- Report Date
- October 6, 2015
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
(B)(4). SINCE CATALOG # IS UNKNOWN IT COULD BE EITHER K06185, K073374, K90140 BASED ON THE INFORMATION THAT THE CELECT WAS IMPLANTED 5 YEARS AGO. INVESTIGATION IS STILL IN PROGRESS.
MANUFACTURER REFERENCE PR# (B)(4). SINCE CATALOG # IS UNKNOWN IT COULD BE EITHER K06185, K073374, K90140 BASED ON THE INFORMATION THAT THE CELECT WAS IMPLANTED 5 YEARS AGO. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: INVESTIGATION IS BASED ON IMAGING PROVIDED AND A REVIEW OF SAID IMAGING FOUND ALL FOUR PRIMARY LEGS HAD PERFORATED IVC; 2 LEGS WITH GRADE 2 AND 2 LEGS WITH GRADE 3. THE SECONDARY LEGS ARE ALL CONTAINED WITHIN THE EXPECTED LUMEN OF THE IVC. AS TO FILTER RETRIEVAL WITH MODERATE DISCOMFORT, THIS WOULD BE EXPECTED GIVEN THE DEGREE OF PERFORATION. THE HYDRONEPHROSIS APPEARS TO BE DIRECTLY RELATED TO A URETERAL STENOSIS. PATIENT'S MEDICAL RECORDS DURING FILTER IMPLANT PERIOD IS UNKNOWN, BUT PERFORATION PUBLISHED IN SCIENTIFIC LITERATURE DESCRIBES THAT MANIPULATION IN THE AREA OF FILTER PLACEMENT COULD CONTRIBUTE TO CHANGES TO THE FILTER CONFIGURATION AND PLACEMENT THEREBY POTENTIALLY INITIATE TILT OR PERFORATION OF THE VENA CAVA WALL. DIFFICULT FILTER RETRIEVAL DUE TO EMBEDMENT OF FILTER LEGS IN THE IVC WALL IS A WELL-KNOWN RISK IN THE LITERATURE. SEVERAL CASE REPORTS PUBLISHED IN ARTICLES, DESCRIBE SUCCESSFUL ENDOVASCULAR RETRIEVALS OF SUCH FILTERS BY ADVANCED RETRIEVAL TECHNIQUES. THE EXACT REASON FOR THE REPORTED PENETRATION CANNOT BE DETERMINED, BUT 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.
(B)(4). CATALOG # UNKNOWN BUT REFERRED TO AS CELECT FILTER. EXPIRATION DATE UNKNOWN AS LOT # IS UNKNOWN. SINCE CATALOG # IS UNKNOWN IT COULD BE EITHER K06185, K073374, K90140 BASED ON THE INFORMATION THAT THE CELECT WAS IMPLANTED 5 YEARS AGO. MFR DATE UNKNOWN SINCE LOT # IS UNKNOWN. SUMMARY OF INVESTIGATIONAL FINDINGS: (B)(4) 2015: INVESTIGATION IS BASED ON IMAGING PROVIDED AND A REVIEW OF SAID IMAGING FOUND ALL FOUR PRIMARY LEGS HAD PERFORATED IVC; 2 LEGS WITH GRADE 2 AND 2 LEGS WITH GRADE 3. THE SECONDARY LEGS ARE ALL CONTAINED WITHIN THE EXPECTED LUMEN OF THE IVC. AS TO FILTER RETRIEVAL WITH MODERATE DISCOMFORT, THIS WOULD BE EXPECTED GIVEN THE DEGREE OF PERFORATION. THE HYDRONEPHROSIS APPEARS TO BE DIRECTLY RELATED TO A URETERAL STENOSIS PATIENT'S MEDICAL RECORDS DURING FILTER IMPLANT PERIOD IS UNKNOWN, BUT PERFORATION PUBLISHED IN SCIENTIFIC LITERATURE DESCRIBES THAT MANIPULATION IN THE AREA OF FILTER PLACEMENT COULD CONTRIBUTE TO CHANGES TO THE FILTER CONFIGURATION AND PLACEMENT THEREBY POTENTIALLY INITIATE TILT OR PERFORATION OF THE VENA CAVA WALL. DIFFICULT FILTER RETRIEVAL DUE TO EMBEDMENT OF FILTER LEGS IN THE IVC WALL IS A WELL-KNOWN RISK IN THE LITERATURE. SEVERAL CASE REPORTS PUBLISHED IN ARTICLES, DESCRIBE SUCCESSFUL ENDOVASCULAR RETRIEVALS OF SUCH FILTERS BY ADVANCED RETRIEVAL TECHNIQUES. THE EXACT REASON FOR THE REPORTED PENETRATION CANNOT BE DETERMINED, BUT 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. ADDITIONAL INFORMATION 29DEC2016: APPROXIMATELY 5 YEARS AFTER CELECT FILTER PLACEMENT ONE PRIMARY FILTER LEG PERFORATED IVC AND INTERACTED WITH THE RIGHT URETER AND TWO OTHER PRIMARY LEGS EXTENDED APPROX. 2.3CM AND 19MM OUTSIDE THE IVC, RESPECTIVELY. THE FILTER DEMONSTRATED APPROXIMATELY 20° OF LEFTWARD TILT. THERE IS NO DISCUSSION OF THE POTENTIAL CAUSES OF PENETRATION IN THIS CASE SPECIFICALLY, BUT RATHER THE INCREASED LIKELIHOOD OF PENETRATION THE LONGER THE DWELL TIME. GIVEN THE SIGNIFICANT TILT THAT WAS PRESENT ON THE IMAGES AT TIME OF WORKUP AND RETRIEVAL, THIS LIKELY PLAYED A ROLE IN DEVELOPING THE EXTENSIVE PENETRATION. WITHOUT THE PLACEMENT IMAGES, IT IS IMPOSSIBLE TO DETERMINE WHETHER OR NOT THE TILT DEVELOPED AS A COMPLICATION OF THE PENETRATION OR IF THE TILT WAS PRESENT THUS FACILITATED THE PENETRATION. IT IS NOTED THAT THE FILTER WAS REMOVED WITHOUT MUCH DIFFICULTY. 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. INVESTIGATION OF 15DEC2015 IS STILL VALID AND REMAINS UNCHANGED. 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.
MANUFACTURER REFERENCE PR# (B)(4). CATALOG # UNKNOWN BUT REFERRED TO AS CELECT FILTER. EXPIRATION DATE UNKNOWN AS LOT# IS UNKNOWN. SINCE CATALOG # IS UNKNOWN, IT COULD BE EITHER K06185, K073374, K90140 BASED ON THE INFORMATION THAT THE CELECT WAS IMPLANTED 5 YEARS AGO MFR #UNKNOWN SINCE LOT # IS UNKNOWN. SUMMARY OF INVESTIGATIONAL FINDINGS: INVESTIGATION IS BASED ON IMAGING PROVIDED AND A REVIEW OF SAID IMAGING FOUND ALL FOUR PRIMARY LEGS HAD PERFORATED IVC; 2 LEGS WITH GRADE 2 AND 2 LEGS WITH GRADE 3. THE SECONDARY LEGS ARE ALL CONTAINED WITHIN THE EXPECTED LUMEN OF THE IVC. AS TO FILTER RETRIEVAL WITH MODERATE DISCOMFORT, THIS WOULD BE EXPECTED GIVEN THE DEGREE OF PERFORATION. THE HYDRONEPHROSIS APPEARS TO BE DIRECTLY RELATED TO A URETERAL STENOSIS. PATIENT'S MEDICAL RECORDS DURING FILTER IMPLANT PERIOD IS UNKNOWN, BUT PERFORATION PUBLISHED IN SCIENTIFIC LITERATURE DESCRIBES THAT MANIPULATION IN THE AREA OF FILTER PLACEMENT COULD CONTRIBUTE TO CHANGES TO THE FILTER CONFIGURATION AND PLACEMENT THEREBY POTENTIALLY INITIATE TILT OR PERFORATION OF THE VENA CAVA WALL. DIFFICULT FILTER RETRIEVAL DUE TO EMBEDMENT OF FILTER LEGS IN THE IVC WALL IS A WELL-KNOWN RISK IN THE LITERATURE. SEVERAL CASE REPORTS PUBLISHED IN ARTICLES, DESCRIBE SUCCESSFUL ENDOVASCULAR RETRIEVALS OF SUCH FILTERS BY ADVANCED RETRIEVAL TECHNIQUES. THE EXACT REASON FOR THE REPORTED PENETRATION CANNOT BE DETERMINED, BUT 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.
DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: PATIENT PRESENTED WITH HYDRO NEPHROSIS. UPON CT SCAN, IT WAS DETERMINED THAT CELECT PENETRATED THE CAVAL WALL. PATIENT UNDERWENT RETRIEVAL WITH MODERATE DISCOMFORT, AND THE FILTER WAS REMOVED WITH MINIMAL DIFFICULTY. IT WAS NOTED FILTER WAS PLACED 5 YRS AGO.
DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: PATIENT PRESENTED WITH HYDRO NEPHROSIS. UPON CT SCAN, IT WAS DETERMINED THAT CELECT PENETRATED THE CAVAL WALL. PATIENT UNDERWENT RETRIEVAL WITH MODERATE DISCOMFORT, AND THE FILTER WAS REMOVED WITH MINIMAL DIFFICULTY. IT WAS NOTED FILTER WAS PLACED 5 YRS AGO. ADDITIONAL INFORMATION RECEIVED ON 03NOV2016: A (B)(6) WOMAN PRESENTED WITH A 1-MONTH HISTORY OF FLUCTUATING ABDOMINAL AND RIGHT FLANK PAIN. ON INITIAL PRESENTATION, SHE WAS AFEBRILE AND HAD NORMAL VITALS. PHYSICAL EXAMINATION REVEALED MILD DIFFUSE ABDOMINAL TENDERNESS AND MILD RIGHT COSTOVERTEBRAL ANGLE TENDERNESS. LABORATORY EVALUATION WAS LARGELY UNREMARKABLE WITHOUT LEUKOCYTOSIS OR ELEVATED SERUM CREATININE. MICROSCOPIC URINALYSIS DID NOT SHOW PYURIA OR HEMATURIA. A CT OF THE ABDOMEN AND PELVIS WAS OBTAINED IN THE EMERGENCY ROOM, WHICH REVEALED MODERATE RIGHT HYDRONEPHROSIS SECONDARY TO AN ERODED IVC FILTER LIMB PROJECTING IN THE RIGHT PROXIMAL URETERAL LUMEN (FIGS. 1 AND 2). HER COMPLICATED HISTORY HAD LED TO MULTIPLE PREVIOUS CT SCANS, ALLOWING FOR RADIOGRAPHIC TRACKING OF GRADUAL MIGRATION OF THE FILTER LIMB INTO THE URETER ON SEQUENTIAL SCANS. THE PATIENT WAS EVALUATED BY THE UROLOGY, VASCULAR SURGERY, AND INTERVENTIONAL RADIOLOGY SERVICES. AS THERE WAS NO EVIDENCE OF RENAL COMPROMISE, INFECTION, HEMATURIA, OR HEMODYNAMIC COMPROMISE, NO EMERGENT INTERVENTION WAS PERFORMED. REVIEW OF HER MEDICAL HISTORY REVEALED THAT HER PRIOR DVTS HAD OCCURRED DURING PREVIOUS PERIODS OF PROLONGED IMMOBILITY. SHE WAS CURRENTLY MUCH MORE PHYSICALLY ACTIVE. A HYPERCOAGULABILITY WORK-UP WAS NEGATIVE. DUE TO THESE FACTORS AND THE SYMPTOMATIC EROSION OF HER FILTER, DECISION WAS MADE FOR RETRIEVAL OF THE FILTER. THIS WAS EFFECTIVELY PERFORMED THROUGH AN ENDOVASCULAR APPROACH BY THE INTERVENTIONAL RADIOLOGY SERVICE, USING THE RIGHT INTERNAL JUGULAR VEIN FOR ACCESS. THE FILTER RETRIEVAL HOOK WAS NOT EMBEDDED IN THE CAVAL WALL, WHICH ALLOWED IT TO BE SNARED EASILY WITH A FILTER RETRIEVAL DEVICE. AFTER THIS, THE ENTIRE FILTER WAS WITHDRAWN BACK INTO A SHEATH AND REMOVED. CONCOMITANTLY, PERCUTANEOUS ACCESS FOR ANTEGRADE NEPHROSTOGRAM WAS PERFORMED (FIG. 3), WHICH REVEALED SOME NARROWING AT THE SITE OF PENETRATION BUT NO CONTRAST EXTRAVASATION. PATIENT OUTCOME: THE PATIENT DID REQUIRE AN ADDITIONAL FILTER REMOVAL PROCEDURE DUE TO THIS OCCURRENCE. IT IS POSSIBLE THAT THIS OCCURRENCE CONTRIBUTED TO HYDRO NEPHROSIS.
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PATIENT PRESENTED WITH HYDRO NEPHROSIS. UPON CT SCAN, IT WAS DETERMINED THAT CELECT PENETRATED THE CAVAL WALL. PATIENT UNDERWENT RETRIEVAL WITH MODERATE DISCOMFORT, AND THE FILTER WAS REMOVED WITH MINIMAL DIFFICULTY. IT WAS NOTED FILTER WAS PLACED 5 YRS AGO. ADDITIONAL INFORMATION RECEIVED ON 03NOV2016: A (B)(6) WOMAN PRESENTED WITH A 1-MONTH HISTORY OF FLUCTUATING ABDOMINAL AND RIGHT FLANK PAIN. ON INITIAL PRESENTATION, SHE WAS AFEBRILE AND HAD NORMAL VITALS. PHYSICAL EXAMINATION REVEALED MILD DIFFUSE ABDOMINAL TENDERNESS AND MILD RIGHT COSTOVERTEBRAL ANGLE TENDERNESS. LABORATORY EVALUATION WAS LARGELY UNREMARKABLE WITHOUT LEUKOCYTOSIS OR ELEVATED SERUM CREATININE. MICROSCOPIC URINALYSIS DID NOT SHOW PYURIA OR HEMATURIA. A CT OF THE ABDOMEN AND PELVIS WAS OBTAINED IN THE EMERGENCY ROOM, WHICH REVEALED MODERATE RIGHT HYDRONEPHROSIS SECONDARY TO AN ERODED IVC FILTER LIMB PROJECTING IN THE RIGHT PROXIMAL URETERAL LUMEN (FIGS. 1 AND 2). HER COMPLICATED HISTORY HAD LED TO MULTIPLE PREVIOUS CT SCANS, ALLOWING FOR RADIOGRAPHIC TRACKING OF GRADUAL MIGRATION OF THE FILTER LIMB INTO THE URETER ON SEQUENTIAL SCANS. THE PATIENT WAS EVALUATED BY THE UROLOGY, VASCULAR SURGERY, AND INTERVENTIONAL RADIOLOGY SERVICES. AS THERE WAS NO EVIDENCE OF RENAL COMPROMISE, INFECTION, HEMATURIA, OR HEMODYNAMIC COMPROMISE, NO EMERGENT INTERVENTION WAS PERFORMED. REVIEW OF HER MEDICAL HISTORY REVEALED THAT HER PRIOR DVTS HAD OCCURRED DURING PREVIOUS PERIODS OF PROLONGED IMMOBILITY. SHE WAS CURRENTLY MUCH MORE PHYSICALLY ACTIVE. A HYPERCOAGULABILITY WORK-UP WAS NEGATIVE. DUE TO THESE FACTORS AND THE SYMPTOMATIC EROSION OF HER FILTER, DECISION WAS MADE FOR RETRIEVAL OF THE FILTER. THIS WAS EFFECTIVELY PERFORMED THROUGH AN ENDOVASCULAR APPROACH BY THE INTERVENTIONAL RADIOLOGY SERVICE, USING THE RIGHT INTERNAL JUGULAR VEIN FOR ACCESS. THE FILTER RETRIEVAL HOOK WAS NOT EMBEDDED IN THE CAVAL WALL, WHICH ALLOWED IT TO BE SNARED EASILY WITH A FILTER RETRIEVAL DEVICE. AFTER THIS, THE ENTIRE FILTER WAS WITHDRAWN BACK INTO A SHEATH AND REMOVED. CONCOMITANTLY, PERCUTANEOUS ACCESS FOR ANTEGRADE NEPHROSTOGRAM WAS PERFORMED (FIG. 3), WHICH REVEALED SOME NARROWING AT THE SITE OF PENETRATION BUT NO CONTRAST EXTRAVASATION. PATIENT OUTCOME: THE PATIENT DID REQUIRE AN ADDITIONAL FILTER REMOVAL PROCEDURE DUE TO THIS OCCURRENCE. IT IS POSSIBLE THAT THIS OCCURRENCE CONTRIBUTED TO HYDRO NEPHROSIS.
DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: PATIENT PRESENTED WITH HYDRO NEPHROSIS. UPON CT SCAN, IT WAS DETERMINED THAT CELECT PENETRATED THE CAVAL WALL. PATIENT UNDERWENT RETRIEVAL WITH MODERATE DISCOMFORT, AND THE FILTER WAS REMOVED WITH MINIMAL DIFFICULTY. IT WAS NOTED FILTER WAS PLACED 5 YRS AGO. PATIENT OUTCOME: THE PATIENT DID REQUIRE AN ADDITIONAL FILTER REMOVAL PROCEDURE DUE TO THIS OCCURRENCE. IT IS POSSIBLE THAT THIS OCCURRENCE CONTRIBUTED TO HYDRO NEPHROSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 710979 | UNKNOWN | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |