ESPRIT¿
Report
- Report Number
- 2024168-2025-11824
- Event Type
- Injury
- Date Received
- December 1, 2025
- Date of Event
- October 28, 2025
- Report Date
- January 27, 2026
- Manufacturer
- ABBOTT VASCULAR INC.
- Product Code
- NXW
- UDI-DI
- 08717648357015
- PMA / PMN Number
- P230036
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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. THE REPORTED PATIENT EFFECT OF OCCLUSION IS LISTED IN THE ESPRIT BTK EVEROLIMUS ELUTING RESORBABLE SCAFFOLD SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, 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; THEREFORE, NO PRODUCT-RELATED CORRECTIVE ACTION WILL BE IMPLEMENTED IN THIS CASE. CORRECTIONS: D4 - MODEL #, CATALOG #: UPDATED FROM 1203250-38 TO 1203300-38. D4 - LOT #: UPDATED FROM 5052961 TO 5052061. D4 - EXPIRATION DATE: UPDATED FROM 5/28/2027 TO 5/19/2027. D4 - PRIMARY UDI NUMBER: UPDATED FROM (B)(4) TO (B)(4). H4 - DEVICE MFR DATE: UPDATED FROM 5/29/2025 TO 5/20/2025.
B5 - DESCRIBE EVENT OR PROBLEM: UPDATED AS ADDITIONAL INFORMATION WAS RECEIVED.
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. THE REPORTED PATIENT EFFECT OF OCCLUSION IS LISTED IN THE ESPRIT BTK EVEROLIMUS ELUTING RESORBABLE SCAFFOLD SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, 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; THEREFORE, NO PRODUCT-RELATED CORRECTIVE ACTION WILL BE IMPLEMENTED IN THIS CASE.
SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WERE TWO INDEX TARGET LESIONS. THE STUDY SCAFFOLDS WERE IMPLANTED IN THE POSTERIOR TIBIAL ARTERY (PT) AND THE TIBIOPERONEAL TRUNK (TPT). THE 2.5 X 38MM ESPRIT BTK WAS IMPLANTED IN THE PT AND THE 3.0 X38MM ESPRIT BTK WAS IMPLANTED IN THE TPT. THE RESTENOSIS IN THE TPT WAS TREATED WITH ANGIOPLASTY ON (B)(6) 2025, NOT (B)(6) 2025, AS WAS PREVIOUSLY REPORTED. THERE WAS NO RESTENOSIS IN THE PT ESPRIT SCAFFOLD. ONLY THE TPT SCAFFOLD WAS TREATED. THE NEW PT LESION WAS OUTSIDE THE ORIGINAL SCAFFOLD, AND A NEW SCAFFOLD WAS PLACED IN THE NEW PT LESION. NO ADDITIONAL INFORMATION WAS PROVIDED.
SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT ON 10/28/2025 AND 11/03/2025 THE PATIENT'S HEEL WOUND WAS WORSENING AND REQUIRED DEBRIDEMENT AND CALCANECTOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.
PATIENT ID: (B)(4). IT WAS REPORTED THAT ON (B)(6) 2025 TWO ESPRIT BTK SCAFFOLDS (SIZES 2.5X38 AND 3.0X38 MM) WERE IMPLANTED IN THE RIGHT, MID POSTERIOR TIBIAL ARTERY. ON (B)(6) 2025 THE PATIENT'S WOUND HAD NOT BEEN HEALING WELL. REPEAT ANGIOGRAM FOUND RESTENOSIS. THIS WAS TREATED WITH ANGIOPLASTY ON (B)(6) 2025. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 502801 | ESPRIT¿ | SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE | NXW | ABBOTT VASCULAR INC. | 1203300-38 | 5052061 | 08717648357015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Male | Required Intervention| H | SCAFFOLD: ESPRIT BTK 3.0X38 MM |