SMART 7FR 120CM BILIARY 12X80
Report
- Report Number
- 9616099-2018-02264
- Event Type
- Injury
- Date Received
- July 24, 2018
- Date of Event
- May 5, 2016
- Report Date
- August 27, 2018
- Manufacturer
- CORDIS CORPORATION
- Product Code
- FGE
- PMA / PMN Number
- K042969
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
AS REPORTED, THE PATIENT UNDERWENT PLACEMENT OF AN OPTEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT, INCLUDE BUT ARE NOT LIMITED TO, TILT, PERFORATION, FILTER EMBEDDED IN WALL OF THE VENA CAVA, INFERIOR VENA CAVA (IVC) THROMBOSIS, UNSUCCESSFUL REMOVAL ATTEMPT, FILTER UNABLE TO BE RETRIEVED, AND NARROWING OF HER IVC. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN, SUFFERING AND OTHER DAMAGES. THE FOLLOWING IS ADDITIONAL INFORMATION RECEIVED PER THE PATIENT PROFILE FORM, THE PATIENT WAS IN HER USUAL STATE OF GOOD HEALTH UNTIL AROUND ELEVEN (11) YEARS AGO. SHE HAD BEEN STARTED ON THE BIRTH CONTROL PILL ORTHO TRI-CYCLEN FOR POLYCYSTIC OVARIAN SYNDROME. THREE (3) MONTHS LATER, SHE DEVELOPED SHORTNESS OF BREATH AND PRESENTED TO THE EMERGENCY ROOM COMPLAINING OF SHORTNESS OF BREATH TWICE IN THE PRECEDING THREE WEEKS SUGGEST THAT SHE ALSO HAD A PE AT THAT TIME. HOWEVER, NO DIAGNOSIS WAS MADE. ON THE FOLLOWING MONTH, SHE DEVELOPED LEG PAIN, COULD NOT WALK, LEG TURNED BLUE AND COLD TO TOUCH. THE 911 EMERGENCY NUMBER WAS CALLED. SHE WAS ADMITTED AND SIX-DAY HOSPITAL STAY FOLLOWED. SHE WAS DIAGNOSED WITH LEFT LEG DVT WITH PHLEGMASIA COERULEA DOLENS. AN OPTEASE IV FILTER WAS PLACED AND ANGIOJET PROCEDURE PERFORMED, WHICH WAS SUCCESSFUL EXCEPT FOR RESIDUAL CLOT IN THE ILIAC VEIN. THE SECOND ANGIOJET PROCEDURE WAS DONE, BUT THERE WAS STENOSIS OF THE LEFT ILIAC VEIN. BALLOON ANGIOPLASTY WAS DONE, BUT THERE WAS STILL SOME RESIDUAL NARROWING. SHE WAS TREATED WITH ANTICOAGULANTS. A FOLLOW-UP DOPPLER ULTRASOUND ON SHOWED ONE MONTH LATER SHOWED EXTENSIVE DVT THROUGHOUT HER LEFT LEG. A CT SCAN OF THE ABDOMEN AND PELVIS ON ONE MONTH LATER SHOWED "NO ILEOCAVAL THROMBOSIS. ON, TWO MONTHS LATER, ACCESS TO THE IVC WAS ACHIEVED AND THE IVC WAS IDENTIFIED AGAIN AS WIDELY PATENT. EVIDENCE OF CHRONIC CHANGES IN THE CENTRAL LEFT COMMON ILIAC VEIN WERE NOTED, SECONDARY TO THE PATIENT'S KNOWN MAY THURNER SYNDROME. THERE WAS AN ATTEMPT TO REMOVE THE FILTER. APPARENTLY DUE TO FAIRLY LARGE THROMBUS BURDEN THE FILTER WAS NOT REMOVED. THE PHYSICIAN ELECTED TO STENT THE LEFT COMMON AND EXTERNAL VEINS. A 14 MM X 8 CM AND A 12 MM X 6 CM SMART STENTS WERE DEPLOYED. HOWEVER, AFTER THESE WERE DEPLOYED, IT WAS ELECTED TO STENT MORE CAUDALLY, DUE TO THE CHRONIC CHANGES IN THE COMMON FEMORAL VEIN. THEREFORE A 12 MM X 6 CM SMART STENT WAS DEPLOYED, EXTENDING INTO THE COMMON FEMORAL VEIN. FOLLOW-UP VENOGRAM DEMONSTRATED ACUTE THROMBUS WITHIN THE NEWLY PLACED STENT WITH PATENCY OF ROBUST COLLATERALS. IN LIGHT OF THIS, HEMATOLOGY WAS CONSULTED, AND WAS ELECTED TO HEPARINIZE THE PATIENT MORE AGGRESSIVELY. POWER PULSE SPRAY WAS ALSO PERFORMED WITH THE ANGIOJET DEVICE, WITH 10 MG OF TPA MIXED WITH 100 OF SALINE· THROUGH THE NEWLY PLACED STENT. BALLOON MACERATION IS ALSO PERFORMED. THIS DEMONSTRATES SOME IMPROVEMENT WITH A LARGE THROMBUS BURDEN PERSISTING. AT THIS POINT, DUE TO THE EXTENDED LENGTH OF THE PROCEDURE, IT WAS ELECTED TO INITIATE THROMBOLYSIS. A 90 CN1 INFUSLON CATHETER WITL-. 50 CM INFUSION LENGTH WEA DEPLOYED WHICH WAS USED TO INITIATE THROMBOLYSIS. THRORNBOLYTICS WERE INITIATED USING TPA, WITH 1 MG OF TPA/HR BEING INSTILLED VIA THE INFUSION CATHETER. THROMBOLYTIC TO BE -CONTINUED OVERNIGHT. ON THE ONE DAY FOLLOW-UP AFTER INITIATION OF THROMBOLYTICS YESTERDAY EVENING. VENOGRAM WAS PERFORMED THROUGH THE INDWELLING SHEATH ON THE FOLLOWING DAY. THE LEFT PROFUNDA FEMORAL VEIN WAS PATENT WITH CHRONIC CHANGES NOTED CENTRALLY. THE LEFT ILIAC/FEMORAL VENOUS STENT IS WIDELY PATENT. AN UPDATED PATIENT PROFILE FORM INDICATES THERE WAS ALSO CLOTS, CLOTTING AND OCCLUSION OF THE IVC. THE PATIENT REPORTED PROCEDURES TO OPEN UP THE LEG VEINS, LEG SWELLING, INABILITY TO WALK OR STAND FOR LONG PERIODS. THE PATIENT ALSO HAS STRESS AND ANXIETY OF ADDITIONAL FAILURES SUCH AS PERFORATION OF THE IVC OR SURROUNDING ORGANS OR MIGRATION OF THE FILTER. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE PURPOSE OF A VENA CAVA FILTER IS TO CATCH THROMBUS FROM THE LOWER EXTREMITIES AS IT TRAVELS ALONG NORMAL BLOOD FLOW PATTERNS UP TOWARDS THE HEART. WITHOUT PROCEDURAL FILMS AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO CLARIFY THE LOCATION (PROXIMAL OR DISTAL) OF THE CLOTS TO THE PLACEMENT OF THE IVC FILTER. BLOOD CLOTS THAT DEVELOP IN THE VEINS OF THE LEG OR PELVIS, MAY BE RELATED TO A CONDITION CALLED DEEP VEIN THROMBOSIS (DVT). DEEP VEIN THROMBOSIS (DVT) OCCURS WHEN A BLOOD CLOT FORMS IN A DEEP VEIN AND IS MOST COMMON IN THE DEEP VEINS OF THE LOWER LEG (CALF) AND CAN SPREAD UP TO THE VEINS IN THE THIGH. PLACEMENT OF A VENA CAVA FILTER IS NOT A CURE FOR DVT NOR DOES IT PREVENT THE FORMATION OF DVT OR OTHER CLOTS (THROMBOSIS). VENOUS STASIS IS A CONDITION OF SLOW BLOOD FLOW IN THE VEINS. THIS VENOUS INSUFFICIENCY IS SOMETIMES CAUSED BY DVT AND HIGH BLOOD PRESSURE INSIDE THE VEINS. CLINICAL FACTORS THAT MAY HAVE INFLUENCED THE REPORTED EVENTS INCLUDE PATIENT, PHARMACOLOGICAL, LESION CHARACTERISTICS OR OTHER COMORBIDITIES AND NOT NECESSARILY RELATED TO THE IMPLANTATION OF THE FILTER. WITHOUT PROCEDURAL FILMS FOR REVIEW, THE REPORTED FILTER TILT COULD NOT BE CONFIRMED AND THE EXACT CAUSE COULD NOT BE DETERMINED. THE TIMING AND MECHANISM OF THE TILT HAS NOT BEEN REPORTED AT THIS TIME. THE BRIEF ALSO REPORTED PERFORATION; HOWEVER, A CLINICAL CONCLUSION COULD NOT BE DETERMINED AS TO THE CAUSE OF THE EVENT. IT IS UNKNOWN IF THE TILT CONTRIBUTED TO THE REPORTED PERFORATION. A REVIEW OF THE INSTRUCTIONS FOR USE NOTES VESSEL DAMAGE SUCH AS INTIMAL TEARS AND PERFORATION AS PROCEDURAL COMPLICATIONS RELATED IT IVC FILTERS. THE IMPLANTATION DATE OF THE FILTER AND THE ATTEMPTED RETRIEVAL DATE ARE UNKNOWN AT THIS TIME. RETRIEVAL OF THE OPTEASE VENA CAVA FILTER IS INDICATED UP TO 23 DAYS POST IMPLANTATION. USAGE OF THE PRODUCT OTHER THAN THAT INDICATED IN THE PRODUCT'S IFU MAY INVOLVE ADDITIONAL RISKS NOT DESCRIBED IN THE LABELING. THE PREDOMINANT CONCERN IS THE DEVELOPMENT OF ENDOTHELIALIZATION, WHICH WOULD MAKE SUBSEQUENT REMOVAL DIFFICULT. ENDOTHELIALIZATION, REMODELING/RESTRUCTURING OF THE VESSEL WALL FOLLOWING DEVICE IMPLANTATION, IS THE BODY¿S NATURAL RESPONSE AND HAS BEEN SHOWN TO OCCUR IN AS SHORT A PERIOD AS 12 DAYS. IT WAS ALSO MENTIONED IN THE MEDICAL RECORDS THAT THE IMPLANTED SMART STENT DEVELOPED A THROMBOSIS. THROMBOSIS AND TREATMENT FOR THROMBOSIS DOES NOT REPRESENT A DEVICE MALFUNCTION. CLINICAL FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PHARMACOLOGICAL AND LESION CHARACTERISTICS. BASED ON THE MINIMAL INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION OR DETERMINE A ROOT CAUSE FOR THE REPORTED EVENTS. GIVEN THE LIMITED INFORMATION AVAILABLE FOR REVIEW AT THIS TIME, THERE IS NOTHING TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO THE DESIGN AND MANUFACTURING PROCESS OF THE DEVICE; THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY. THIS IS ONE OF TWO REPORTS ASSOCIATED WITH THE SAME PATIENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURING REPORT NUMBERS 1016427-2017-00721 AND 9616099-2018-02264.
CONCOMITANT MEDICAL PRODUCTS: PROVERA 10MG, GABAPENTIN 300MG, ESCITALOPRAM OXALATE, LORATADINE 10MG, METFORMIN 500MG. THE PRODUCT REMAINS IMPLANTED AND IS THUS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
AS REPORTED BY THE LEGAL DEPARTMENT, THE PATIENT UNDERWENT PLACEMENT OF AN OPTEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT, INCLUDE BUT ARE NOT LIMITED TO, TILT, PERFORATION, FILTER EMBEDDED IN WALL OF THE NC, NC THROMBOSIS, UNSUCCESSFUL REMOVAL ATTEMPT, FILTER UNABLE TO BE RETRIEVED, AND NARROWING OF HER NC. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN, SUFFERING AND OTHER DAMAGES. THE FOLLOWING IS ADDITIONAL INFORMATION RECEIVED PER THE PATIENT PROFILE FORM, THE PATIENT WAS IN HER USUAL STATE OF GOOD HEALTH UNTIL 11 YEARS AGO. SHE HAD BEEN STARTED ON THE BIRTH CONTROL PILL ORTHO TRI-CYCLEN FOR POLYCYSTIC OVARIAN SYNDROME. THREE MONTHS LATER, SHE DEVELOPED SHORTNESS OF BREATH AND PRESENTED TO THE EMERGENCY ROOM TWICE. OF SHORTNESS OF BREATH IN THE PRECEDING THREE WEEKS SUGGEST THAT SHE ALSO HAD A PE AT THAT TIME. HOWEVER, NO DIAGNOSIS WAS MADE. ON THE FOLLOWING MONTH, SHE DEVELOPED LEG PAIN, COULD NOT WALK, LEG TURNED BLUE AND COLD TO TOUCH. 911 WAS CALLED. SHE WAS ADMITTED AND SIX-DAY HOSPITAL STAY FOLLOWED. SHE WAS DIAGNOSED WITH LEFT LEG DVT WITH PHLEGMASIA COERULEA DOLENS. AN OPTEASE IV FILTER WAS PLACED AND ANGIOJET PROCEDURE PERFORMED, WHICH WAS SUCCESSFUL EXCEPT FOR RESIDUAL CLOT IN THE ILIAC VEIN. THE SECOND ANGIOJET PROCEDURE WAS DONE, BUT THERE WAS STENOSIS OF THE LEFT ILIAC VEIN. BALLOON ANGIOPLASTY WAS DONE, BUT THERE WAS STILL SOME RESIDUAL NARROWING. SHE WAS TREATED WITH ANTICOAGULANTS. A FOLLOW-UP DOPPLER ULTRASOUND ON SHOWED ONE MONTH LATER SHOWED EXTENSIVE DVT THROUGHOUT HER LEFT LEG. A CT SCAN OF THE ABDOMEN AND PELVIS ON ONE MONTH LATER SHOWED "NO ILEOCAVAL THROMBOSIS. ON, TWO MONTHS LATER, ACCESS TO THE IVC WAS ACHIEVED AND THE IVC WAS IDENTIFIED AGAIN AS WIDELY PATENT. EVIDENCE OF CHRONIC CHANGES IN THE CENTRAL LEFT COMMON ILIAC VEIN WERE NOTED, SECONDARY TO THE PATIENT'S KNOWN MAY TURNER SYNDROME. THERE WAS AN ATTEMPT TO REMOVE THE FILTER. APPARENTLY DUE TO FAIRLY LARGE THROMBUS BURDEN THE FILTER WAS NOT REMOVED. THE PHYSICIAN ELECTED TO STENT THE LEFT COMMON AND EXTERNAL VEINS. A 14 MM X 8 CM AND A 12 MM X 6 CM SMART STENTS WERE DEPLOYED. HOWEVER, AFTER THESE WERE DEPLOYED, IT WAS ELECTED TO STENT MORE CAUDALLY, DUE TO THE CHRONIC CHANGES IN THE COMMON FEMORAL VEIN. THEREFORE A 12 MM X 6 CM SMART STENT WAS DEPLOYED, EXTENDING INTO THE COMMON FEMORAL VEIN. FOLLOW-UP VENOGRAM DEMONSTRATED ACUTE THROMBUS WITHIN THE NEWLY PLACED STENT WITH PATENCY OF ROBUST COLLATERALS. IN LIGHT OF THIS, HEMATOLOGY WAS CONSULTED, AND WAS ELECTED TO HEPARINIZE THE PATIENT MORE AGGRESSIVELY. POWER PULSE SPRAY WAS ALSO PERFORMED WITH THE ANGIOJET DEVICE, WITH 10 MG OF TPA MIXED WITH 100 OF SALINE· THROUGH THE NEWLY PLACED STENT. BALLOON MACERATION IS ALSO PERFORMED. THIS DEMONSTRATES SOME IMPROVEMENT WITH A LARGE THROMBUS BURDEN PERSISTING. AT THIS POINT, DUE TO THE EXTENDED LENGTH OF THE PROCEDURE, IT WAS ELECTED TO INITIATE THROMBOLYSIS. A 90 CN1 INFUSLON CATHETER WITL-.50 CM INFUSION LENGTH WE.A DEPLOYED WHICH WAS USED TO INITIATE THROMBOLYSIS. THROMBOLYTICS WERE INITIATED USING TPA, WITH 1 MG OF TPA/HR BEING INSTILLED VIA THE INFUSION CATHETER. THROMBOLYTIC TO BE -CONTINUED OVERNIGHT. ON THE ONE DAY FOLLOW-UP AFTER INITIATION OF THROMBOLYTICS YESTERDAY EVENING. VENOGRAM WAS PERFORMED THROUGH THE INDWELLING SHEATH ON THE FOLLOWING DAY. THE LEFT PROFUNDA FEMORAL VEIN WAS PATENT WITH CHRONIC CHANGES NOTED CENTRALLY. THE LEFT ILIAC/FEMORAL VENOUS STENT IS WIDELY PATENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 557982 | SMART 7FR 120CM BILIARY 12X80 | SELF EXPANDABLE STENTS | FGE | CORDIS CORPORATION | N/A | 15073016 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Hospitalization| L| R | WARFARIN 1MG| WARFARIN 1MG |