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	Unspecified Vascular Problem (4441); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
(b)(4).It was reported that on (b)(6) 2025 two 3.5x38 mm esprit btk scaffolds were implanted in the right peroneal artery.On (b)(6) 2025 the patient had an overnight hospital stay following a revascularization procedure in the anterior tibial artery.The patient was observed to be short of breath and weak after going to the bathroom.He was less responsive to commands and became increasingly hypoxic until respiratory therapy was called.The patient then lost his pulse, went into cardiac arrest and required intubation.He was admitted to the cardiac care unit for post cardiac arrest management.His course was complicated by oliguric kidney injury, metabolic/lactic acidosis.The patient was discharged on (b)(6) 2025 where his final diagnosis was peripheral artery disease status post intervention complicated by cardiac arrest, end stage renal disease with hemodialysis, and dysphagia.The dysphagia was related to the patient's prolonged intubation for mechanical ventilation.The patient continued on hemodialysis after he was discharged on (b)(6) 2025.On (b)(6) 2025, the patient was reported deceased by a family member when the patient was at another hospital.No additional information was provided.
Event or Problem Description
N/a.
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 effect of death is listed in the esprit btk everolimus eluting resorbable scaffold system instructions for use as a known patient effect of coronary scaffolding procedures.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.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.
Event or Problem Description
Subsequent to the previously filed report, additional information was received that the patient was admitted to the hospital with a rectal bleed on (b)(6) 2025.Colonoscopy revealed a perirectal hematoma which was controlled.In the opinion of the physician, the esprit btk scaffold is not related to the patient death.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.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.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: b3 - date of event: updated from 11/12/2025 to 11/3/2025.B5 - describe event or problem: updated, as additional information was provided.H6 - health effect - clinical code: code 4441 was removed and code 4582 was added.H6 - health effect - impact code: codes 1802 and 4607 were removed and code 4657 was added.H11 - additional mfr narrative: updated based on additional information.

• 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: 23771553
• Report Number: 2024168-2025-11947
• Device Sequence Number: 16110058
• Product Code: NXW
• UDI-Device Identifier: 08717648357091
• UDI-Public: (01)08717648357091(11)240712(17)260711(10)407126A
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P230036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup,Followup
• Report Date (Section B): 01/19/2026

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: 07/11/2026
• Device Model Number: 1203350-38
• Device Catalogue Number: 1203350-38
• Device Lot Number: 407126A
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 12/11/2025; 01/08/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 12/30/2025; 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2024
• 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: Death
• Patient Age: 88 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White