MAUDE Adverse Event Report: ABBOTT VASCULAR INC. Esprit¿; Scaffold,infrapopliteal,absorbable

Model Number	1212300-38
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Diminished Pulse Pressure (2606); Thrombosis/Thrombus (4440)
Date of Event	08/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat a de novo lesion in the tibioperoneal trunk (tpt) with 80% stenosis and heavy calcification; and popliteal and also a small area in the superficial femoral artery (sfa).Two (2) 3.0x38mm esprit btk stent were implanted to treat the tpt and intravascular lithotripsy (ivl) 3.0x 80 was used to treat the popliteal and the superficial femoral artery (sfa).A few hours later, the patient lost pulse.Re-angiography was performed and the popliteal and tpt scaffolds were clotted off.A non-abbott thrombectomy balloon system was used to get the popliteal and scaffold open.Additionally, medication (tissue plasminogen activator) was administered.A dissection in the popliteal was observed which was treated with a non-abbott covered stent.In the physician's opinion, the 2 esprit btk stents did not cause or contribute to the dissection.Post-dilatation was performed with a non-abbott 3.0x120mm balloon.Result was decent.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 effect(s) of thrombosis is listed in the esprit btk everolimus eluting resorbable scaffold system over-the-wire (otw) instructions for use as a known patient effect(s) of scaffolding procedures.A conclusive cause for the reported patient effect(s), 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 additional device referenced in b5 is filed under separate medwatch report number.C3: 1 per year was entered; however, the frequency is 1 dose per implant.

• Brand Name: Esprit¿
• Common Device Name: Scaffold,infrapopliteal,absorbable
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 -280
• Manufacturer (Section G): ABBOTT VASCULAR, Reg # 2024168; 26531 ynez road; temecula CA 92591 -462
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591--462 ; +1(951)914-5259
• MDR Report Key: 50847026
• Report Number: 2024168-2026-03638
• Device Sequence Number: 9935973
• Product Code: NXW
• UDI-Device Identifier: 08717648354021
• UDI-Public: (01)08717648354021(11)260601(17)280531(10)6060161
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P230036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: 1212300-38
• Device Catalogue Number: 1212300-38
• Device Lot Number: 6060161
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2026
• 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: 3x120 Coyote; ESPRIT BTK OTW 3.0 x 38
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown