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

Model Number	1203375-38
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Obstruction/Occlusion (2422)
Date of Event	08/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 occlusion and pain are listed in the esprit btk everolimus eluting resorbable scaffold systems instructions for use as a 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 reported treatment appears to be related to 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 other device referenced in b5 is being filed under a separate medwatch report number.
Event or Problem Description
(b)(4).It was reported that on (b)(6) 2025, two 3.75x38 mm esprit btk scaffolds were implanted in the left lower limb: one in the tibio-peroneal trunk to the posterior tibial artery and the second in the peroneal artery.Two non-target lesions on the left lower limb were also treated at the index study procedure.Two days post procedure, on (b)(6) 2025, the patient was seen in the emergency room with worsening foot pain in the index limb.It was determined that the limb pain is likely secondary to acute reperfusion from arterialization of the posterior tibial vein.The patient was treated with a heparin intravenous drip.The condition resolved on (b)(6) 2025.On (b)(6) 2025, the patient was seen in the clinic for a follow-up visit.The patient was admitted for scans and observations.The computed tomography angiography (cta) scan found an occluded left superficial femoral artery and no flow in the calf arteries.The foot was not salvageable.Amputation was performed above the left knee on (b)(6) 2025.The patient was discharged from the amputation admission on (b)(6) 2025.On (b)(6) 2025, the patient was found unresponsive at his assisted living facility.The patient's pulse was absent with no rise/fall of the patient's chest.The patient was pronounced dead with the primary symptom listed as cardiac arrest.In the opinion of the physician, the index study devices are not related to the cardiac arrest/ patient demise.There were no ongoing complications from the amputation that contributed to the patient¿s demise.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 of specific issue.The reported patient effects of occlusion and pain 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 reported treatment appears to be related to 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 other device referenced in b5 is being filed under a separate medwatch report number.Corrections: d4 ¿ model #, catalog #: updated from unk esprit btk to 1203375-38.D4 ¿ lot #: updated from unknown to 5050761.D4 - primary udi number: updated from unknown to (b)(4).

• 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: 24006010
• Report Number: 2024168-2026-00160
• Device Sequence Number: 4810619
• Product Code: NXW
• UDI-Device Identifier: 08717648357176
• UDI-Public: (01)08717648357176(11)250507(17)270506(10)5050761
• Combination Product (Y/N): Y
• 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
• Report Date (Section B): 02/02/2026

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 Model Number: 1203375-38
• Device Catalogue Number: 1203375-38
• Device Lot Number: 5050761
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 3.75 X 38 MM ESPRIT SCAFFOLD.
• Outcome Attributed to Adverse Event: Disability; Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White