ESPRIT¿
Report
- Report Number
- 2024168-2025-11131
- Event Type
- Injury
- Date Received
- October 15, 2025
- Date of Event
- September 3, 2025
- Report Date
- October 15, 2025
- Manufacturer
- ABBOTT VASCULAR INC.
- Product Code
- NXW
- UDI-DI
- 08717648357251
- PMA / PMN Number
- P230036
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 SPECIFIC ISSUE. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THE REPORTED PATIENT EFFECT(S) OF THROMBOSIS IS LISTED IN THE ESPRIT BTK EVEROLIMUS ELUTING RESORBABLE SCAFFOLD SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT(S) OF CORONARY STENTING PROCEDURES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED ON (B)(6) 2025 TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS LEFT ANTERIOR TIBIAL ARTERY. THE 2.50X38MM ESPRIT BTK RESORBABLE SCAFFOLD WAS IMPLANTED. IT WAS NOTED THAT DURING SCAFFOLD IMPLANTATION, POST-DILATION WAS NOT PERFORMED. ON (B)(6) 2025, THE PATIENT PRESENTED WITH PAIN IN THE LOWER LEFT LEG AND ANGIOGRAM REVEALED SCAFFOLD THROMBOSIS; HOWEVER, NO TREATMENT WAS GIVEN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2289514 | ESPRIT¿ | SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE | NXW | ABBOTT VASCULAR INC. | 1203250-38 | 5022761 | 08717648357251 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |