ESPRIT¿
Report
- Report Number
- 2024168-2025-12223
- Event Type
- Malfunction
- Date Received
- December 23, 2025
- Date of Event
- December 4, 2025
- Report Date
- January 12, 2026
- Manufacturer
- ABBOTT VASCULAR INC.
- Product Code
- NXW
- UDI-DI
- 08717648357251
- PMA / PMN Number
- P230036
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.
A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED GUIDE WIRE EXIT NOTCH KINK WAS CONFIRMED. THE REPORTED FAILURE TO ADVANCE AND DIFFICULTY TO REMOVE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT OF SPECIFIC ISSUE. BASED ON THE REPORTED INFORMATION AND THE OBSERVATIONS FROM THE RETURNED ANALYSIS, THE INVESTIGATION DETERMINED THAT THE REPORTED ISSUE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MILDLY TORTUOUS LESION IN THE RIGHT PERONEAL ARTERY. THE 2.50X38MM RX ESPRIT BTK SYSTEM MET RESISTANCE WHILE ADVANCING AND DURING REMOVAL DUE TO THE ANATOMY AND THE GUIDE WIRE EXIT NOTCH WAS NOTED TO BE KINKED. A 2.50X38MM OTW ESPRIT BTK SYSTEM WAS ADVANCED AND MET RESISTANCE DUE TO THE ANATOMY THEREFORE IT WAS REMOVED. THE LESION WAS DILATED WITH A BALLOON CATHETER AND THE SAME 2.50X38MM OTW ESPRIT BTK WAS REINTRODUCED INTO THE VESSEL WITHOUT ISSUE AND THE SCAFFOLD IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MILDLY TORTUOUS LESION IN THE RIGHT PERONEAL ARTERY. THE 2.50X38MM RX ESPRIT BTK SYSTEM MET RESISTANCE WHILE ADVANCING AND DURING REMOVAL DUE TO THE ANATOMY AND THE GUIDE WIRE EXIT NOTCH WAS NOTED TO BE KINKED. A 2.50X38MM OTW ESPRIT BTK SYSTEM WAS ADVANCED AND MET RESISTANCE DUE TO THE ANATOMY THEREFORE IT WAS REMOVED. THE LESION WAS DILATED WITH A BALLOON CATHETER AND THE SAME 2.50X38MM OTW ESPRIT BTK WAS REINTRODUCED INTO THE VESSEL WITHOUT ISSUE AND THE SCAFFOLD IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1801817 | ESPRIT¿ | SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE | NXW | ABBOTT VASCULAR INC. | 1203250-38 | 5022761 | 08717648357251 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Male |