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

Model Number	1203375-38
Medical Device Problem Codes	Break (1069); Leak/Splash (1354); Failure to Advance (2524); Material Deformation (2976); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat the mid anterior tibial artery with moderate calcification.The lesion was pre-dilated with a 3.5 mm balloon.The 3.75x38 mm esprit below the knee (btk) delivery system failed to cross the lesion and a smaller esprit btk device was able to cross.There were no adverse patient effects and there was no clinically significant delay in the procedure.Returned device analysis identified that there was fluid leaking from a hole in the outer member, a tear in the guide wire exit notch and a broken strut.The account stated the stent was noted to be crimped upon removal.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection, functional testing, dimensional analysis were performed on the returned device.The reported scaffold deformation was confirmed.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.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 is likely the device interacted with the moderately calcified tibial artery during advancement to the lesion causing the reported failure to advance and subsequent deformation of the scaffold.A smaller sized scaffold successfully crossed the lesion indicating the esprit btk3.75 x38 mm device may have been too large for the intended lesion.Additionally, the delivery system was returned with significant damage (bent/kinked/torn outer member, bent hypotube and torn guide wire notch).The account indicated they were only aware of the stent deformation.It is likely the delivery system damage is due to handling and/or manipulation of the device during the procedure and/or during post procedure handling.The observed torn outer member was located at a place of what appears to be an extreme fatigue to the outer member due to kinking.It is likely that handling of the device during the reported difficulties advancing resulted in the severe outer member kink and subsequent torn outer member material.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.

• 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: 22375278
• Report Number: 2024168-2025-06788
• Device Sequence Number: 12750875
• Product Code: NXW
• UDI-Device Identifier: 08717648357176
• UDI-Public: (01)08717648357176(11)240611(17)250610(10)4061161
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P230036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/01/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/10/2025
• Device Model Number: 1203375-38
• Device Catalogue Number: 1203375-38
• Device Lot Number: 4061161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: .014 300 CM THRUWAY; 7FR ANSEL SHEATH
• Patient Age: 73 YR
• Patient Sex: Male