EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U
Report
- Report Number
- 2015691-2020-13417
- Event Type
- Death
- Date Received
- September 3, 2020
- Date of Event
- July 7, 2020
- Report Date
- June 26, 2023
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- NPT
- PMA / PMN Number
- P140031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
A MEDWATCH REPORT (MW5096847) WAS RECEIVED, SUBMITTED BY THE HOSPITAL. THE INFORMATION DOES NOT CHANGE THE PREVIOUSLY REPORTED INFORMATION. INVESTIGATION IS ONGOING.
THE COMMANDER DELIVERY SYSTEM WAS NOT RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. THE 3MENSIO IMAGERY PROVIDED SHOWS THE RIGHT ACCESS VESSEL ANATOMY WITH DOUBLE 90 DEGREE BENDS AND CALCIFICATION. VESSEL DIAMETERS ARE WITHIN RECOMMENDED USE OF THE 14F ESHEATH. A DHR REVIEW WAS PERFORMED AND DID NOT REVEAL ANY MANUFACTURING NON-CONFORMANCE ISSUES THAT WOULD HAVE CONTRIBUTED TO THE COMPLAINT EVENT. A LOT HISTORY REVIEW WAS PERFORMED AND REVEALED NO OTHER COMPLAINTS RELATING TO A THV VALVE DISLODGED FROM THE DELIVERY SYSTEM BALLOON. AS THE EVENT WAS UNABLE TO BE CONFIRMED, A COMPLAINT HISTORY REVIEW IS NOT REQUIRED. THE INSTRUCTIONS FOR USE (IFU) AND TRAINING MANUALS WERE REVIEWED FOR GUIDANCE AND INSTRUCTION ON DEVICE PREPARATION AND USAGE INVOLVING THE DELIVERY SYSTEM. THE OPERATOR IS INSTRUCTED TO CORRECTLY ORIENT DELIVERY SYSTEM AND CHECK POSITION BEFORE INSERTION. ORIENT THE DELIVERY SYSTEM WITH THE FLUSH PORT POINTING AWAY AND THE EDWARDS LOGO FACING UP. ENSURE DELIVERY SYSTEM IS LOCKED IN DEFAULT POSITION. ASPIRATE AS NECESSARY DURING DELIVERY SYSTEM INSERTION. TAKE CARE WHEN HANDLING. DO NOT BEND SYSTEM EITHER AT THE HANDLE OR TIP. MAINTAIN EDWARDS LOGO UP THROUGHOUT THE PROCEDURE TO PREVENT KINKING OF THE DELIVERY SYSTEM. INSERTION FORCE THROUGH THE PARTIALLY EXPANDABLE PORTION CAN BE HIGHER THAN THE PUSH FORCE THROUGH THE FULLY EXPANDABLE PORTION. IN EXPECTATION OF HIGH FRICTION, USE SHORT MOVEMENTS AND PUSH DELIVERY SYSTEM CLOSER TO SHEATH HUB. PUSH FORCE CAN VARY DUE TO ANGLE OF ACCESS AND INSERTION, THV SIZE, VESSEL DIAMETER, TORTUOSITY AND DEGREE OF CALCIFICATION. FOLLOWING PROPER VALVE CRIMPING TECHNIQUE AND ENSURE VALVE IS DELIVERED AS STRAIGHT AS POSSIBLE. BE CAREFUL TO NOT BEND THE PROXIMAL END OF THE SHEATH WHEN INSERTING THE DELIVERY SYSTEM THROUGH THE SHEATH. IF PUSH FORCE IS HIGH OR VALVE IS INITIALLY STUCK, ZOOM IN AND ROTATE THE C-ARM TO ENSURE VALVE AND SHEATH ARE NOT DAMAGED. IF DAMAGED, RETRACT VALVE IN SHEATH SLIGHTLY. REMOVE VALVE AND SHEATH TOGETHER AS SINGLE UNIT AND REPLACE. IF PUSH FORCE IS HIGH, CONSIDER SLIGHTLY PULLING BACK THE SHEATH 1-2 CM WHILE ADVANCING THE THV/DELIVERY SYSTEM. IF PUSH FORCE IS TOO HIGH OR VALVE IS STILL STUCK, REMOVE VALVE AND SHEATH TOGETHER AS SINGLE UNIT AND REPLACE. DO NOT OVER-MANIPULATE THE SHEATH AT ANY TIME. THE THV SHOULD NOT BE ADVANCED THROUGH THE SHEATH IF THE SHEATH TIP IS NOT ABOVE THE RENAL ARTERIES. TO PREVENT POSSIBLE LEAFLET DAMAGE, THE THV SHOULD NOT REMAIN IN THE SHEATH FOR OVER 5 MINUTES. THV CAN BE RETRIEVED THROUGH SHEATH ONLY BEFORE THV DEPLOYMENT (STILL CRIMPED). ENSURE THE THV IS CENTERED ON THE FLEX TIP. ENSURE DELIVERY SYSTEM IS LOCKED. RETRACT THE THV AND DELIVERY SYSTEM INTO THE SHEATH ENSURING THE THV IS COMPLETELY INSIDE THE SHEATH AND JUST PAST THE SHEATH TIP. ENSURE THE EDWARDS LOGO ON THE SHEATH HANDLE IS FACING UPWARD. WITHDRAW THE DELIVERY SYSTEM AND SHEATH AS A SINGLE UNIT COMPLETELY FROM THE ARTERIOTOMY WHILE MAINTAINING GUIDEWIRE POSITION. DO NOT RE-USE THE SHEATH, THV OR DELIVERY SYSTEM ONCE THV IS RETRIEVED. CRIMPED THV ALIGNED ON BALLOON IS LARGER THAN CRIMPED THV OFF BALLOON. TAKE CARE IF DECIDING TO RETRIEVE. DO NOT FORCE THE THV INTO THE SHEATH. IF RESISTANCE IS FELT, THE THV MAY BE CAUGHT ON THE SHEATH TIP. STOP, ADVANCE THV PAST THE SHEATH TIP AND ENSURE THV IS CENTERED ON THE FLEX TIP. ROTATE THE DELIVERY SYSTEM BEFORE TRYING AGAIN. BASED ON THE REVIEW OF THE IFU/TRAINING MANUALS, NO DEFICIENCIES WERE IDENTIFIED. DURING MANUFACTURING OF THE COMMANDER DELIVERY SYSTEM, THE DELIVERY SYSTEM AND COMPONENTS ARE INSPECTED SEVERAL TIMES THROUGHOUT THE MANUFACTURING PROCESS. IN ADDITION, PRODUCT VERIFICATION TESTING WAS PERFORMED ON A SAMPLING BASIS AND ALL TESTING MET SPECIFICATIONS. THESE INSPECTIONS PERFORMED DURING MANUFACTURING PROCESS AND TESTING PERFORMED DURING PRODUCT VERIFICATION SUPPORT THAT IT IS UNLIKELY THAT A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE REPORTED EVENTS. THE VALVE DISLODGED FROM BALLOON EVENT WAS UNABLE TO BE CONFIRMED. A REVIEW OF MANUFACTURING MITIGATIONS SUPPORTS THAT THE DELIVERY SYSTEM HAS PROPER INSPECTIONS IN PLACE TO DETECT ISSUES RELATED TO THE COMPLAINT EVENTS. A REVIEW OF IFU/TRAINING MATERIALS REVEALED NO DEFICIENCIES. DHR AND LOT HISTORY REVIEW REVEALED THAT IT IS UNLIKELY A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE COMPLAINT EVENT. AS MENTIONED IN THE DESCRIPTION, ¿THE 26MM VALVE WAS ADVANCED INTO THE SHEATH, BUT BECAME HUNG UP IN THE MID TO DISTAL SEGMENT OF THE SHEATH [...] DURING ATTEMPTS TO COMPLETELY WITHDRAW THE ESHEATH, THE VALVE CAME OUT OF THE SHEATH AND WAS IN THE EXTERNAL ILIAC ARTERY.¿ IF THE SHEATH WAS DAMAGED, IT IS LIKELY THAT DURING ATTEMPTED WITHDRAWAL THAT THE DELIVERY SYSTEM INTERACTED WITH THE NATIVE ANATOMY. PER THE 3MENSIO REPORT, THE PATIENT¿S ACCESS VESSEL HAD DOUBLE 90-DEGREE BENDS AND CALCIUM. CALCIFICATION AND TORTUOSITY CAN CREATE A DIFFICULT PATHWAY FOR SHEATH AND DELIVERY SYSTEM DURING ATTEMPTED WITHDRAWAL. IT IS LIKELY THAT EXCESSIVE DEVICE MANIPULATION WAS USED TO OVERCOME THESE PATIENT FACTORS, RESULTING IN THE DISLODGEMENT OF THE VALVE FROM THE BALLOON. WHILE A DEFINITIVE ROOT CAUSE IS UNABLE TO BE DETERMINED, AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS (CALCIFICATION/TORTUOSITY) AND/OR PROCEDURAL FACTORS (EXCESSIVE MANIPULATION) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENTS. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS MONTHLY, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. A REVIEW OF EDWARDS LIFESCIENCES RISK MANAGEMENT DOCUMENTATION WAS PERFORMED FOR THIS CASE. THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVE PROCEDURE, ADDITIONAL ASSESSMENT OF THE FAILURE MODE IS NOT REQUIRED AT THIS TIME. SINCE NO EDWARDS DEFECT, WHICH COULD HAVE RESULTED IN THE COMPLAINT, WAS CONFIRMED NO PREVENTATIVE OR CORRECTIVE ACTIONS ARE REQUIRED. ADDITIONALLY, SINCE NO PRODUCT NON-CONFORMANCES OR IFU/TRAINING DEFICIENCIES WERE IDENTIFIED DURING EVALUATION, A PRODUCT RISK ASSESSMENT ESCALATION IS NOT REQUIRED.
THE EVALUATION WAS UPDATED BASED ON THE IMAGERY RECEIVED. THE COMMANDER DELIVERY SYSTEM WAS NOT RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. A DHR REVIEW WAS PERFORMED AND DID NOT REVEAL ANY MANUFACTURING NON-CONFORMANCE ISSUES THAT WOULD HAVE CONTRIBUTED TO THE COMPLAINT EVENT. A LOT HISTORY REVIEW WAS PERFORMED AND REVEALED NO OTHER COMPLAINTS RELATING TO A THV VALVE DISLODGED FROM THE DELIVERY SYSTEM BALLOON. THE 3MENSIO SHOWS ON THE RIGHT FEMORAL ACCESS SHARP TORTUOSITY OF THE EXTERNAL ILIAC ARTERY AND COMMON ILIAC ARTERY (90-DEGREE ANGLES) WHICH IS CONSIDERED CHALLENGING ANATOMY AND CAN CAUSE CHALLENGES ADVANCING THE SYSTEM THROUGH, REGARDLESS OF DIAMETERS OF THE ARTERY. AFTER THE PREPROCEDURAL ILIAC ANGIOGRAPHY, THE FIRST IMAGE PROVIDED SHOWS THE TIP OF THE ESHEATH IN THE RIGHT ILIAC (WITH THE 26MM SAPIEN 3 ULTRA CRIMPED, NOT MOUNTED ON THE DELIVERY SYSTEM, BUT WITHIN THE SHEATH). AT THIS POINT, ALL THE MANEUVERS RESPONSIBLE FOR THE ILIAC RUPTURE HAVE ALREADY HAPPENED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS MONTHLY, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. THE INSTRUCTIONS FOR USE (IFU ) AND TRAINING MANUALS WERE REVIEWED FOR GUIDANCE AND INSTRUCTION ON DEVICE PREPARATION AND USAGE INVOLVING THE DELIVERY SYSTEM. THE OPERATOR IS INSTRUCTED TO CORRECTLY ORIENT DELIVERY SYSTEM AND CHECK POSITION BEFORE INSERTION. ORIENT THE DELIVERY SYSTEM WITH THE FLUSH PORT POINTING AWAY AND THE EDWARDS LOGO FACING UP. ENSURE DELIVERY SYSTEM IS LOCKED IN DEFAULT POSITION. ASPIRATE AS NECESSARY DURING DELIVERY SYSTEM INSERTION. TAKE CARE WHEN HANDLING. DO NOT BEND SYSTEM EITHER AT THE HANDLE OR TIP. MAINTAIN EDWARDS LOGO UP THROUGHOUT THE PROCEDURE TO PREVENT KINKING OF THE DELIVERY SYSTEM. INSERTION FORCE THROUGH THE PARTIALLY EXPANDABLE PORTION CAN BE HIGHER THAN THE PUSH FORCE THROUGH THE FULLY EXPANDABLE PORTION. IN EXPECTATION OF HIGH FRICTION, USE SHORT MOVEMENTS AND PUSH DELIVERY SYSTEM CLOSER TO SHEATH HUB. PUSH FORCE CAN VARY DUE TO ANGLE OF ACCESS AND INSERTION, THV SIZE, VESSEL DIAMETER, TORTUOSITY AND DEGREE OF CALCIFICATION. FOLLOWING PROPER VALVE CRIMPING TECHNIQUE AND ENSURE VALVE IS DELIVERED AS STRAIGHT AS POSSIBLE. BE CAREFUL TO NOT BEND THE PROXIMAL END OF THE SHEATH WHEN INSERTING THE DELIVERY SYSTEM THROUGH THE SHEATH. IF PUSH FORCE IS HIGH OR VALVE IS INITIALLY STUCK, ZOOM IN AND ROTATE THE C-ARM TO ENSURE VALVE AND SHEATH ARE NOT DAMAGED. IF DAMAGED, RETRACT VALVE IN SHEATH SLIGHTLY. REMOVE VALVE AND SHEATH TOGETHER AS SINGLE UNIT AND REPLACE. IF PUSH FORCE IS HIGH, CONSIDER SLIGHTLY PULLING BACK THE SHEATH 1-2 CM WHILE ADVANCING THE THV/DELIVERY SYSTEM. IF PUSH FORCE IS TOO HIGH OR VALVE IS STILL STUCK, REMOVE VALVE AND SHEATH TOGETHER AS SINGLE UNIT AND REPLACE. DO NOT OVER-MANIPULATE THE SHEATH AT ANY TIME. THE THV SHOULD NOT BE ADVANCED THROUGH THE SHEATH IF THE SHEATH TIP IS NOT ABOVE THE RENAL ARTERIES. TO PREVENT POSSIBLE LEAFLET DAMAGE, THE THV SHOULD NOT REMAIN IN THE SHEATH FOR OVER 5 MINUTES. THV CAN BE RETRIEVED THROUGH SHEATH ONLY BEFORE THV DEPLOYMENT (STILL CRIMPED). ENSURE THE THV IS CENTERED ON THE FLEX TIP. ENSURE DELIVERY SYSTEM IS LOCKED. RETRACT THE THV AND DELIVERY SYSTEM INTO THE SHEATH ENSURING THE THV IS COMPLETELY INSIDE THE SHEATH AND JUST PAST THE SHEATH TIP. ENSURE THE EDWARDS LOGO ON THE SHEATH HANDLE IS FACING UPWARD. WITHDRAW THE DELIVERY SYSTEM AND SHEATH AS A SINGLE UNIT COMPLETELY FROM THE ARTERIOTOMY WHILE MAINTAINING GUIDEWIRE POSITION. DO NOT RE-USE THE SHEATH, THV OR DELIVERY SYSTEM ONCE THV IS RETRIEVED. CRIMPED THV ALIGNED ON BALLOON IS LARGER THAN CRIMPED THV OFF BALLOON. TAKE CARE IF DECIDING TO RETRIEVE. DO NOT FORCE THE THV INTO THE SHEATH. IF RESISTANCE IS FELT, THE THV MAY BE CAUGHT ON THE SHEATH TIP. STOP, ADVANCE THV PAST THE SHEATH TIP AND ENSURE THV IS CENTERED ON THE FLEX TIP. ROTATE THE DELIVERY SYSTEM BEFORE TRYING AGAIN. BASED ON THE REVIEW OF THE IFU/TRAINING MANUALS, NO DEFICIENCIES WERE IDENTIFIED. DURING MANUFACTURING OF THE COMMANDER DELIVERY SYSTEM, THE DELIVERY SYSTEM AND COMPONENTS ARE INSPECTED SEVERAL TIMES THROUGHOUT THE MANUFACTURING PROCESS. IN ADDITION, PRODUCT VERIFICATION TESTING WAS PERFORMED ON A SAMPLING BASIS AND ALL TESTING MET SPECIFICATIONS. THESE INSPECTIONS PERFORMED DURING MANUFACTURING PROCESS AND TESTING PERFORMED DURING PRODUCT VERIFICATION SUPPORT THAT IT IS UNLIKELY THAT A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE REPORTED EVENTS. A REVIEW OF EDWARDS LIFESCIENCES RISK MANAGEMENT DOCUMENTATION WAS PERFORMED FOR THIS CASE. THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVE PROCEDURE, ADDITIONAL ASSESSMENT OF THE FAILURE MODE IS NOT REQUIRED AT THIS TIME. SINCE NO EDWARDS DEFECT, WHICH COULD HAVE RESULTED IN THE COMPLAINT WAS CONFIRMED, NO PREVENTATIVE OR CORRECTIVE ACTIONS ARE REQUIRED. ADDITIONALLY, SINCE NO PRODUCT NON-CONFORMANCES OR IFU/TRAINING DEFICIENCIES WERE IDENTIFIED DURING EVALUATION, A PRODUCT RISK ASSESSMENT ESCALATION IS NOT REQUIRED. THE COMPLAINT VALVE DISLODGING FROM THE DELIVERY SYSTEM BALLOON WAS CONFIRM ED AS IMAGERY SHOWED THE VALVE NOT MOUNTED ON THE DELIVERY SYSTEM. A REVIEW OF MANUFACTURING MITIGATIONS SUPPORTS THAT THE DELIVERY SYSTEM HAS PROPER INSPECTIONS IN PLACE TO DETECT ISSUES RELATED TO THE COMPLAINT EVENTS. A REVIEW OF IFU/TRAINING MATERIALS REVEALED NO DEFICIENCIES. DHR, LOT HISTORY, AND COMPLAINT HISTORY REVIEW REVEALED THAT IT IS UNLIKELY A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE COMPLAINT EVENT. AS MENTIONED IN THE DESCRIPTION , ''THE 26MM VALVE WAS ADVANCED INTO THE SHEATH, BUT BECAME HUNG UP IN THE MID TO DISTAL SEGMENT OF THE SHEATH [...] DURING ATTEMPTS TO COMPLETELY WITHDRAW THE ESHEATH, THE VALVE CAME OUT OF THE SHEATH AND WAS IN THE EXTERNAL ILIAC ARTERY.'' IF THE SHEATH WAS DAMAGED, IT IS LIKELY THAT DURING ATTEMPTED WITHDRAWAL THAT THE DELIVERY SYSTEM INTERACTED WITH THE NATIVE ANATOMY. PER THE 3MENSIO REPORT, THE PATIENT'S ACCESS VESSEL HAD DOUBLE 90 DEGREE BENDS AND CALCIUM. CALCIFICATION AND TORTUOSITY CAN CREATE A DIFFICULT PATHWAY FOR SHEATH AND DELIVERY SYSTEM DURING ATTEMPTED WITHDRAWAL. IT IS LIKELY THAT EXCESSIVE DEVICE MANIPULATION WAS USED TO OVERCOME THESE PATIENT FACTORS, RESULTING IN THE DISLODGEMENT OF THE VALVE FROM THE BALLOON. WHILE A DEFINITIVE ROOT CAUSE IS UNABLE TO BE DETERMINED, AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS (CALCIFICATION/TORTUOSITY) AND/OR PROCEDURAL FACTORS (EXCESSIVE MANIPULATION) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENTS.
PLEASE REFERENCE ADDITIONAL RELATED MANUFACTURER REPORT NO: 2015691-2023-12028 ADDED ADDITIONAL H.6 TYPE OF INVESTIGATION CODE. IMAGERY WAS RECEIVED FOR EVALUATION. A REVIEW OF THE IMAGERY CONFIRMED THE PATIENT HAD A CHALLENGING ANATOMY OF THE RIGHT ILIAC ARTERIES WITH DOUBLE 90-DEGREE (OR MORE) ANGLES OF THE COMMON ILIAC, WITH SIGNIFICANT CALCIFICATION RIGHT AT THE FIRST KINK. NO IMAGING WAS PROVIDED OF THE ISSUES DESCRIBED ADVANCING THE COMMANDER DELIVERY SYSTEM THROUGH THE SHEATH. NO IMAGES WERE RECEIVED SHOWING THE VALVE COMING OFF THE DELIVERY SYSTEM AND COMING OUT OF THE ESHEATH. THE FIRST IMAGE SHOWS THE 26MM SAPIEN 3 ULTRA VALVE CRIMPED WITH A BENT STRUT, NOT ON THE DELIVERY SYSTEM BUT WITHIN THE SHEATH. CONTRAST INJECTION SHOWS EXTRAVASATION IN THE COMMON/EXTERNAL RIGHT ILIAC ARTERY. MULTIPLE BALLOON OCCLUSIONS AND COVERED STENTS WERE PLACED IN THE RIGHT ILIAC ARTERY. ANTEROGRADE FLOW FROM THE ABDOMINAL AORTA ARTERY WAS NOT VISUALIZED, RETROGRADE FROM FEMORAL ACCESS WAS VISUALIZED.
UDI: (B)(4). THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2020-12784. INVESTIGATION IS ONGOING.
AS REPORTED, DURING A RIGHT TRANSFEMORAL TAVR CASE, WHILE ADVANCING A 26MM SAPIEN 3 ULTRA VALVE THROUGH THE ESHEATH RESISTANCE WAS FELT. THE ESHEATH BUCKLED WITHIN THE RIGHT COMMON ILIAC. THE RIGHT ILIAC WAS TORN. NON-EDWARDS STENTS WERE PLACED, HOWEVER THE PATIENT BLED INTO THE ABDOMEN. THE PATIENT EXPIRED ON THE TABLE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE FCS. THE RESISTANCE WAS NOTED WHEN THE DELIVERY SYSTEM AND VALVE WERE ABOUT HALFWAY INTO THE SHEATH, WHEN THE VALVE WAS IN THE COMMON ILIAC. THE LOADER WAS FULLY INSERTED AND THE DELIVERY SYSTEM WAS IN THE DEFAULT POSITION. THE PATIENT'S VESSEL MLD WAS 8MM, WITH MILD TORTUOSITY AND MILD CALCIFICATION. THE INSERTION ANGLE WAS AVERAGE. THE VESSEL WAS NOT PRE-DILATED AND THE SHEATH WAS INSERTED WITH EASE. THE SHEATH IS AVAILABLE FOR RETURN AND EVALUATION BUT IS FIRST BEING HELD ON TO BY THE HOSPITAL'S RISK MANAGEMENT TEAM. THE TERRITORY MANAGER, WAS HAVING A DISCUSSION WITH THE PHYSICIAN AND HE STATED, ¿I HAVE A FEELING THE VALVE WAS ¿SNOWPLOWING¿ INTO THE SHEATH, GOT STUCK, KINKED THE SHEATH AND THEN THEN ADDITIONAL PUSHING MADE THE WHOLE THING FLIP OVER AND RUPTURE THE VESSEL.¿ THE 26MM VALVE WAS ADVANCED INTO THE ESHEATH AND BECAME ¿HUNG UP¿ IN THE MID TO DISTAL SEGMENT OF THE SHEATH. DURING ADDITIONAL ADVANCEMENT, THE ENTIRE SHEATH ROTATED AND CREATED A 360 DEGREE LOOP IN THE ILIAC. THERE WAS IMMEDIATE CONCERN FOR ILIAC VESSEL RUPTURE. DURING ATTEMPTS TO WITHDRAW THE ESHEATH AND DELIVERY SYSTEM, THE VALVE CAME OUT OF THE SHEATH AND WAS LEFT IN THE EXTERNAL ILIAC ARTERY. AFTER REMOVAL, THE ESHEATH WAS NOTED TO BE COMPLETELY TORN DOWN THE SEAM. THE ESHEATH WAS THEN REPLACED WITH A 16F NON-EDWARDS SHEATH FOR HEMOSTASIS WITH AN 8MM BALLOON ADVANCED FOR ADDITIONAL CONTROL OF THE BLEEDING. AN ANGIOGRAM DEMONSTRATED LARGE RUPTURE OF THE COMMON AND EXTERNAL ILIAC ARTERIES. THE VASCULAR SURGEON ARRIVED AS THE PATIENT WAS INTUBATED AND MASSIVE TRANSFUSION PROTOCOL WAS INITIATED. TWO OVERLAPPING NON-EDWARDS STENTS WERE DEPLOYED FROM THE COMMON TO EXTERNAL ILIAC ARTERY PLACING THE MOST DISTAL STENT INSIDE THE SAPIEN VALVE. THE STENTS WERE POST DILATED WITH A 12 MM BALLOON AND THERE APPEARED TO BE IMPROVEMENT BUT STILL SIGNIFICANT EXTRAVASATION. AN ADDITIONAL COVERED NON-EDWARDS STENT WAS THEN DEPLOYED IN BETWEEN THE TWO PREVIOUS STENTS. THE BLEEDING APPEARED TO BE RESOLVING HOWEVER THE PATIENT THEN DEVELOPED PEA ARREST. CARDIOPULMONARY RESUSCITATION WAS INITIATED AND THERE WAS INITIALLY RETURN TO SPONTANEOUS CIRCULATION. IT WAS THOUGHT THE PATIENT MAY HAVE ABDOMINAL COMPARTMENT SYNDROME AS THE ABDOMEN WAS DISTENDED. AN EMERGENCY LAPARATOMY WAS PERFORMED TO ALLEVIATE THE INTRA-ABDOMINAL PRESSURE, HOWEVER, THE PATIENT DID NOT HAVE ANY RETURN OF SPONTANEOUS CIRCULATION DESPITE THESE MANEUVERS. THE PATIENT EXPIRED IN THE OR SUITE AT 10:32 AM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 954745 | EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | EDWARDS LIFESCIENCES | 9750CM26A | 63118414 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Male | Required Intervention| D | 26MM SAPIEN 3 ULTRA, ESHEATH| 26MM SAPIEN 3 ULTRA, ESHEATH |