ESPRIT BTK RX IDE
Report
- Report Number
- 2024168-2024-08004
- Event Type
- Injury
- Date Received
- July 8, 2024
- Date of Event
- May 16, 2024
- Report Date
- February 27, 2026
- Manufacturer
- ABBOTT VASCULAR INC.
- Product Code
- NXW
- UDI-DI
- 08717648234064
- PMA / PMN Number
- P230036
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B5 - DESCRIBE EVENT OR PROBLEM: UPDATED AS ADDITIONAL INFORMATION WAS RECEIVED.
THE DEVICE WAS NOT 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 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. THE REPORTED PATIENT EFFECTS OF PAIN AND STENOSIS ARE LISTED IN THE ESPRIT BTK EVEROLIMUS ELUTING BIORESORBABLE SCAFFOLD SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. THE ADDITIONAL DEVICE REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.
B5 - DESCRIBE EVENT OR PROBLEM: UPDATED AS ADDITIONAL INFORMATION WAS RECEIVED.
SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT THE 90% STENOSIS AT THE DISTAL STENT EDGE IN THE LEFT TIBIOPERONEAL TRUNK OCCURRED ON (B)(6) 2024 AND WAS TREATED WITH MEDICATION AND REVASCULARIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.
PATIENT ID: (B)(6). IT WAS REPORTED THE PATIENT HAS A HISTORY OF RENAL DISEASE AND PERIPHERAL ARTERY DISEASE. ON (B)(6) 2021, THE PATIENT UNDERWENT STENTING WITH TWO ESPRIT BTK SCAFFOLDS (3.0X38MM AND 3.5X38MM) IN THE TIBIOPERONEAL ARTERY. ON 05/16/2024 THE PATIENT EXPERIENCED PAIN IN THE LEFT LOWER LIMB. ON (B)(6) 2024, THE PATIENT WAS HOSPITALIZED FOR DISCOMFORT AND PAIN IN THE LOWER LIMB. PHYSICAL EXAMINATION SHOWED NON-SWELLING, NON-REDNESS EXTREMITIES, WITH TRACE PULSATION OF LEFT DORSALIS PEDIS. LAB DATA SHOWED IMPAIRED KIDNEY FUNCTIONAL PROFILE AS BASELINE. PER THE CARDIOLOGIST NO CRITICAL LIMB ISCHEMIA WAS FOUND, AND KEEPING THE PATIENT ON REGULAR MEDICATIONS WAS FEASIBLE. DUE TO PERIPHERAL ARTERIAL OCCLUSIVE DISEASE, THE PATIENT WAS ADMITTED FOR FURTHER EVALUATION. IT IS POSSIBLE THE PAIN IS RELATED TO THE ESPRIT SCAFFOLD. ASPIRIN 100 MG AND PLETAAL 100 MG WAS GIVEN ON (B)(6) 2024. THE PATIENT IS IN STABLE CONDITION. ON (B)(6) 2024, A LOWER LIMB DUPLEX ULTRASOUND WAS PERFORMED SHOWING MODERATE STENOSIS OF THE LEFT COMMON FEMORAL ARTERY, FEMORAL ARTERY AND POPLITEAL ARTERY. RESTENOSIS WAS NOT TREATED. PAIN MEDICATION WAS GIVEN AND THE PATIENT WAS DISCHARGED ON (B)(6) 2024. NO ADDITIONAL INFORMATION WAS PROVIDED.
SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT ON (B)(6) 2024 THE PATIENT HAD A WORSENING OF HIS EXISTING CONDITION. THERE WAS 90% STENOSIS AT THE DISTAL SCAFFOLD EDGE IN THE LEFT TIBIOPERONEAL TRUNK. THIS WAS TREATED WITH MEDICATION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 350427 | ESPRIT BTK RX IDE | STENT, INFRAPOPLITEAL, ABSORBABLE | NXW | ABBOTT VASCULAR INC. | 1202300-38 | 00421P5 | 08717648234064 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Male | Required Intervention| H | SCAFFOLD: 3.5X38 MM ESPRIT BTK RX IDE.| SCAFFOLD: ESPRIT BTK 3.5X38MM. |