ESPRIT¿
Report
- Report Number
- 2024168-2024-07653
- Event Type
- Malfunction
- Date Received
- June 26, 2024
- Date of Event
- June 6, 2024
- Report Date
- August 22, 2024
- Manufacturer
- ABBOTT VASCULAR INC.
- Product Code
- NXW
- UDI-DI
- 08717648357251
- PMA / PMN Number
- P230036
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED DIFFICULTY TO ADVANCE AND DIFFICULTY TO REMOVE COULD NOT BE CONFIRMED DUE TO THE CONDITION THE DEVICE WAS RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. A MEDICAL REVIEW WAS PERFORMED BY AN ABBOTT VASCULAR CLINICAL SPECIALIST. THE REVIEWER CONCLUDED THE FOLLOWING: THIS WAS A CASE TO TREAT A MALE PATIENT OF AN UNKNOWN AGE, HEIGHT, WEIGHT, AND PAST MEDICAL HISTORY. THE PATIENT PRESENTED WITH A LESION IN THE RIGHT ANTERIOR TIBIAL ARTERY (AT) THAT WAS REPORTED AS BEING HEAVILY CALCIFIED, MILDLY TORTUOUS, AND 90% STENOSED. THE LEFT FEMORAL ARTERY WAS ACCESSED FOR A CONTRALATERAL ACCESS APPROACH, AND A 6FR 90CM SHEATH WAS ADVANCED. THE VESSEL PREPARATION WAS COMPLETED WITH AN ABBOTT ORBITAL ATHERECTOMY AND AN UNKNOWN BALLOON DILATATION CATHETER. THE ESPRIT BTK SCAFFOLD WAS ADVANCED AND DEPLOYED SUCCESSFULLY. DURING THE REMOVAL OF THE DELIVERY SYSTEM, RESISTANCE WAS FELT WITH THE 6FR 90CM SHEATH, AND THE GUIDEWIRE AND DELIVERY SYSTEM WERE REMOVED AS ONE UNIT. ANOTHER ESPRIT BTK SCAFFOLD WAS ADVANCED, AND IT WAS NOTED THAT IT WAS NOT TRACKING WELL OVER THE WIRE. HOWEVER, THE SCAFFOLD WAS DEPLOYED PROXIMALLY WITHOUT ISSUE. DURING THE REMOVAL ATTEMPT OF THE SECOND ESPRIT DELIVERY SYSTEM, IT WAS REPORTED THAT RESISTANCE WAS FELT AT THE LESION SITE AND THE INTRODUCER SHEATH. THE ENTIRE SYSTEM WAS REMOVED AS ONE UNIT. IT WAS NOTED THAT THERE WAS A CLOT AT THE END OF THE DELIVERY SYSTEM BALLOON. MANY THINGS COULD HAVE CAUSED A CLOT TO BE FOUND ON THE BALLOON. IT WAS NOT REPORTED HOW MUCH HEPARIN THE PATIENT WAS GIVEN DURING THE PROCEDURE, WHAT THEIR ACTIVATED CLOTTING TIME (ACTS) WERE DURING THE PROCEDURE, OR IF THE SHEATH WAS FLUSHED ADEQUATELY FOR ITS LENGTH BETWEEN ALL DEVICE EXCHANGES, NOT JUST WITH THE ESPRIT SCAFFOLDS. MOST LIKELY, THE THROMBUS WAS WITHIN THE 90CM SHEATH DUE TO THE LENGTH OF TIME THE DELIVERY BALLOON WAS IN THE BODY DURING THE REMOVAL ATTEMPTS AFTER EACH DEPLOYMENT. HOWEVER, IT WAS NOT REPORTED HOW MUCH TIME WAS SPENT ON EACH REMOVAL ATTEMPT, BUT IF THE PATIENT IS NOT ADEQUATELY HEPARINIZED OR THE SHEATH ISN¿T FLUSHED ON A REGULAR BASIS OR ADEQUATELY ENOUGH FOR ITS LENGTH, THROMBUS CAN FORM RAPIDLY. DUE TO THE INFORMATION PROVIDED, IT CAN BE DEFINITIVELY STATED THAT THE ESPRIT BTK SCAFFOLD DID NOT CAUSE OR CONTRIBUTE TO THIS PATIENT¿S ACUTE THROMBOSIS. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES AND TREATMENT APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. CORRECTIONS: B1 - ADVERSE EVENT/PRODUCT PROBLEM - ADVERSE EVENT, PRODUCT PROBLEM UPDATED TO PRODUCT PROBLEM. B2 - OUTCOMES ATTRIBUTED TO AE: UPDATED - OTHER SERIOUS REMOVED AND NA ADDED. H1 - TYPE OF REPORTABLE EVENT - UPDATED FROM SERIOUS INJURY TO MALFUNCTION. H6 - HEALTH EFFECT - CLINICAL CODE: CODE 4440 WAS REMOVED AND CODE 4582 WAS ADDED. H6 - HEALTH EFFECT IMPACT CODE: CODE 4644 WAS REMOVED AND CODE 2199 WAS ADDED.
THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED REPORTED DIFFICULTY TO ADVANCE AND DIFFICULTY TO REMOVE COULD NOT BE CONFIRMED DUE TO THE CONDITION THE DEVICE WAS RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. THE REPORTED PATIENT EFFECT OF THROMBOSIS IS LISTED IN THE ESPRIT BTK EVEROLIMUS ELUTING RESORBABLE SCAFFOLD SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECTS OF CORONARY SCAFFOLD PROCEDURES. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES AND TREATMENT APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.
MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE ADDITIONAL DEVICE REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.
N/A.
SUBSEQUENT TO THE INITIALLY FILED MDR REPORT, THE 0.014 COMMAND GUIDE WIRE WAS RETURNED FROZEN IN THE LUMEN OF THE BVS. THE ACCOUNT STATED THAT THE GUIDE WIRE WAS REMOVED TOGETHER WITH THE BVS BY CHOICE OF THE PHYSICIAN DUE TO THE RESISTANCE THAT WAS FELT ONLY WITH THE ESPRIT BVS DURING REMOVAL. THE GUIDE WIRE HAD SCRATCHED TEFLON AT 72 CM PROXIMAL TO THE DISTAL TIP.
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE HEAVILY CALCIFIED, MILDLY TORTUOUS AND 90% STENOSED RIGHT ANTERIOR TIBIAL ARTERY. A CONTRALATERAL APPROACH WAS USED. A 6FRENCH 90CM SHEATH WAS USED FOR ACCESS AND VESSEL PREPARATION WAS PERFORMED WITH ORBITAL ATHERECTOMY AND PRE-DILATATION USING AN UNSPECIFIED BALLOON. THE ESPRIT BTK BIORESORBABLE SCAFFOLD SYSTEM (BVS) WAS ADVANCED OVER A 0.014¿ COMMAND GUIDEWIRE AND THE SCAFFOLD WAS DEPLOYED IN THE MID DISTAL LESION WITHOUT ISSUE. DURING WITHDRAWAL OF THE DELIVERY SYSTEM BALLOON, RESISTANCE WAS FELT WITH THE INTRODUCER SHEATH, AND THE GUIDE WIRE AND BVS DELIVERY SYSTEM WERE REMOVED TOGETHER. A SECOND PLANNED ESPRIT BTK BVS WAS ADVANCED TO THE TARGET LESION WITHOUT RESISTANCE; HOWEVER, IT WAS NOTED TO NOT BE TRACKING AS WELL OVER THE WIRE DURING POSITIONING. THE SCAFFOLD WAS DEPLOYED PROXIMAL WITHOUT ISSUE. UPON WITHDRAWAL OF THE BVS DELIVERY SYSTEM, RESISTANCE WAS FELT WITH THE VESSEL STENOSIS AND THE INTRODUCER SHEATH; THEREFORE, BOTH WERE RETRACTED TOGETHER INTACT. A CLOT WAS NOTED TO BE ON THE END OF THE DELIVERY SYSTEM BALLOON. THE PATIENT WAS EXPERIENCING ACUTE THROMBUS, WHICH WAS TREATED WITH ADMINISTRATION OF ADDITIONAL HEPARIN. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 654798 | ESPRIT¿ | STENT, INFRAPOPLITEAL, ABSORBABLE | NXW | ABBOTT VASCULAR INC. | 1203250-38 | 4040361 | 08717648357251 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Other | 0.014 COMMAND GUIDE WIRE.| UNSPECIFIED 6FR SHEATH. |