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

Model Number	1203375-38
Medical Device Problem Codes	Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a tibial artery.During advancement of the 3.75x38mm esprit btk resorbable scaffold delivery system (sds) over a 0.014 non-abbott guide wire, difficulty was noted due to anatomy.The sds was removed and reinserted into the patient when the scaffold dislodged inside the patient prior to deployment.A portion of the scaffold was simply withdrawn, and the remaining portion of the scaffold was stented against the target lesion with a non-abbott stent.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported shaft separation was confirmed.The reported scaffold separation could not be confirmed as the scaffold was not returned.The reported failure to advance could not be replicated in a testing environment as it was related to operational context of the procedure.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.It was reported that the stent delivery system (sds) was removed and reinserted into the patient when the scaffold dislodged inside the patient prior to deployment.It should be noted that the esprit btk everolimus eluting resorbable scaffold system instruction for use (ifu) states: an unexpanded scaffold may be retracted into the introducer sheath one time only.Movement in and out through the distal end of the introducer sheath should not be performed, as the scaffold may be damaged or dislodged during retraction back into the introducer sheath.In this case, it is unknown if the ifu deviation related to re-insertion contributed to the reported event.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported issue appears to be related to circumstances of the procedure as it was reported that the device met resistance during advancement due to the patient¿s anatomy causing the reported failure to advance.The dislodged portion of the scaffold that remained was stented against the target lesion with a non-abbott stent.Based on the results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
Returned device analsysis found that the separated portion including the balloon and the scaffold separation was not returned.\ \ follow up information reported that the scaffold dislodged from the balloon prior to the separation.The portion of the scaffold that was simply withdrawn was still attached to the balloon.Shaft separation also occurred during the procedure, and the distal portion of the shaft was simply withdrawn.No additional information was provided.

• 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: 25223007
• Report Number: 2024168-2026-02061
• Device Sequence Number: 15905200
• Product Code: NXW
• UDI-Device Identifier: 08717648357176
• UDI-Public: (01)08717648357176(11)260128(17)280127(10)6012861
• Combination Product (Y/N): Y
• Initial Reporter State: NE
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 6012861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Supplement Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 07/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown