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

Model Number	1203375-38
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional device referenced in b5 is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the posterior tibial with moderate calcification and no tortuosity.The 3.75x38mm esprit btk system was prepared according to the instruction for use (ifu); however, when removing the sheath there was resistance.When an attempt was made to advance the system over the command guide wire there was resistance and the esprit became stuck.The esprit was never inserted into the patient anatomy; however the guide wire had to be removed from the patient with the esprit on the proximal end of the wire.A non-abbott guide wire and a new esprit were used to complete the procedure successfully.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the posterior tibial with moderate calcification and no tortuosity.The 3.75x38mm esprit btk system was prepared according to the instruction for use (ifu); however, when removing the sheath there was resistance.When an attempt was made to advance the system over the command guide wire there was resistance and the esprit became stuck.The esprit was never inserted into the patient anatomy; however the guide wire had to be removed from the patient with the esprit on the proximal end of the wire.A non-abbott guide wire and a new esprit were used to complete the procedure successfully.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported difficulty to remove the protective sheath could not be confirmed as it was related to operational context of the procedure.The reported difficulty to advance and difficulty to remove (guide wire) were confirmed as the device was returned with the procedural guide wire frozen inside of it.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, a definitive cause for the reported issues could not be determined.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 performed to treat a lesion in the posterior tibial with moderate calcification and no tortuosity.The 3.75x38mm esprit btk system was prepared according to the instruction for use (ifu); however, when removing the sheath there was resistance.When an attempt was made to advance the system over the command guide wire there was resistance and the esprit became stuck.The esprit was never inserted into the patient anatomy; however the guide wire had to be removed from the patient with the esprit on the proximal end of the wire.A non-abbott guide wire and a new esprit were used to complete the procedure successfully.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported difficulty to remove the protective sheath could not be confirmed as it was related to operational context of the procedure.The reported difficulty to advance and difficulty to remove (guide wire) were confirmed as the device was returned with the procedural guide wire frozen inside of it.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.Factors that could contribute to difficulty removing the protective sheath include, but are not limited to, damage during manufacturing, inadvertent mishandling during removal from packaging/preparation of the device.In this case, the inner diameter of the sheath was measured and was with specification.Additionally, difficult to advance/remove (guide wire resistance) may be attributed to several factors including, but not limited to, inner diameter of guide wire lumen, outer diameter of the guide wire, condition of the guide wire, damage to the catheter or accumulation of blood or contrast.It should be noted that the guide wire portion that was not frozen with the device was measured and met product specification standards.No other damage to the guide wire that could contribute to the reported difficulties was noted.In this case, it is possible a buildup of procedural contaminants may have contributed to the reported difficulty to advance/remove over the guide wire; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 21293706
• Report Number: 2024168-2025-01206
• Device Sequence Number: 13061125
• Product Code: NXW
• UDI-Device Identifier: 08717648357176
• UDI-Public: (01)08717648357176(11)240506(17)250505(10)4050661
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• 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,Followup,Followup
• Report Date (Section B): 05/21/2025

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: 05/05/2025
• Device Model Number: 1203375-38
• Device Catalogue Number: 1203375-38
• Device Lot Number: 4050661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2025
• Supplement Date Received by Manufacturer: 02/17/2025; 05/19/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 02/25/2025; 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2024
• 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
• Patient Age: 83 YR
• Patient Sex: Male