ESPRIT¿
Report
- Report Number
- 2024168-2026-01587
- Event Type
- Injury
- Date Received
- April 17, 2026
- Date of Event
- March 28, 2026
- Report Date
- April 17, 2026
- Manufacturer
- ABBOTT VASCULAR INC.
- Product Code
- NXW
- PMA / PMN Number
- P230036
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE PRODUCTION RECORDS FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR COMPLAINT QUERY COULD NOT BE PERFORMED BECAUSE THE PART NUMBER AND/OR LOT NUMBER WAS NOT REPORTED, AND THE DEVICE WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF ISCHEMIA AND STENOSIS ARE LISTED IN THE ESPRIT BTK EVEROLIMUS ELUTING RESORBABLE SCAFFOLD SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT OF ISCHEMIA AND STENOSIS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED; HOWEVER, THE SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.
IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE ANTERIOR TIBIAL ARTERY. THE ESPRIT BTK SCAFFOLD WAS IMPLANTED ON (B)(6) 2026 WITHOUT ISSUE. TWO DAYS POST PROCEDURE THE PATIENT RETURNED WITH ISCHEMIA. ANGIOGRAPHY NOTED RESTENOSIS WITHIN THE SCAFFOLD. AMPUTATION SURGERY WAS PLANNED FOR A LATER DATE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 29222 | ESPRIT¿ | STENT, INFRAPOPLITEAL, ABSORBABLE | NXW | ABBOTT VASCULAR INC. | UNK ESPRIT BTK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |