MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ESPRIT¿; SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE

Model Number	1203350-38
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia (1942); Pain (1994); Stenosis (2263)
Date of Event	06/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient id: (b)(6).It was reported that on (b)(6) 2024, one 3.5x38 mm esprit scaffold was implanted in the right anterior tibial artery (ata).That same day, three 6.0 mm stents were also implanted in the superficial femoral artery (sfa).The patient was discharged home the same day, (b)(6) 2024.On (b)(6) 2025 the patient had worsening claudication symptoms in both legs; however, the pain on the right leg was greater.There was no pain at rest and there was no tissue loss.An outpatient diagnostic angiogram showed diminished perfusion to the right leg.The sfa, popliteal artery, tibioperonealtrunk, and peroneal artery were 100% stenosed.The ata was 100% stenosed at the origin with reconstitution through the profunda to geniculate collaterals and patent through the calf down to the level of the ankle where there was narrowing and then beyond to the foot.Only a small portion of the ata had stenosis.The patient was not admitted to the hospital.The patient was given fentanyl and versed as part of the procedural pain management.The patient had an office visit with the physician on (b)(6) 2025.The physician does not recommend intervention at this time.No additional information was provided.
Additional Manufacturer Narrative
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 effects of pain, 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 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.

• Brand Name: ESPRIT¿
• Common Device Name: SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 22384371
• Report Number: 2024168-2025-06839
• Device Sequence Number: 7138696
• Product Code: NXW
• UDI-Device Identifier: 08717648357091
• UDI-Public: (01)08717648357091(11)240508(17)250507(10)4050861
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P230036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/07/2025
• Device Model Number: 1203350-38
• Device Catalogue Number: 1203350-38
• Device Lot Number: 4050861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White