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

Model Number	1203300-38
Medical Device Problem Codes	Break (1069); Failure to Advance (2524); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection and dimensional analysis were performed on the returned device.The reported failure to advance could not be replicated in a testing environment as it was related to operational circumstances.Based on the reported information and the observations from the returned analysis, a definitive cause for the reported issue could not be determined.Factors that could contribute to failure to advance include, but are not limited to, patient anatomical morphology, patient disease state, pre-dilatation strategy, device placement technique, interaction with previously placed stents/scaffolds or accessory device support.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
It was reported that the procedure was to treat the superficial femoral artery with no calcification.The 3.0x38 mm esprit btk device failed to cross the lesion.Another esprit btk also failed as well as an unspecified coronary stent.It is not known the reason of the no cross.There were no adverse patient effects.Plain old balloon angioplasty was performed to complete the procedure.Returned device analysis identified that the skive was separated distal to the outer member to hypotube seal and a tear was noted on the outer member.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: 25337495
• Report Number: 2024168-2026-02197
• Device Sequence Number: 5368922
• Product Code: NXW
• UDI-Device Identifier: 08717648357015
• UDI-Public: (01)08717648357015(11)260113(17)280112(10)6011361
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1203300-38
• Device Catalogue Number: 1203300-38
• Device Lot Number: 6011361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2026
• 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
• Patient Sex: Unknown