MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Model Number	1804350-15
Medical Device Problem Codes	Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation of the 3.5x15mm xience skypoint stent delivery system (sds), the metal stylet was stuck/unable to be removed and the tip was noted to bent.The device was flushed per instructions for use (ifu) and prepped prior to stylet removal.There was no device use or patient involvement.There was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history did not indicate a lot specific quality issue.A conclusive cause for the reported difficulties cannot be determined; however, difficult to remove (stylet/guidewire resistance) may be attributed to several factors including, but are not limited to, inner diameter of guide wire lumen, outer diameter of the guide wire/stylet, condition of the guide wire/stylet, or accumulation of blood or contrast.Factors that could contribute to deformation due to compressive stress prior to use include, but are not limited to, damage during manufacturing, inadvertent mishandling during unpackaging, sheath/stylet removal or during preparation of the device.In this case, it is possible that inadvertent mishandling during preparation of the device and/or sheath/stylet removal may have contributed to the reported difficulty removing the stylet, causing the reported deformation due to compressive stress (kinked tip); however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling.D9 - device available for evaluation updated from ¿yes¿ to ¿no¿.

• Brand Name: XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 15735254
• Report Number: 2024168-2022-11247
• Device Sequence Number: 2868867
• Product Code: NIQ
• UDI-Device Identifier: 08717648233395
• UDI-Public: 08717648233395
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• 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
• Report Date (Section B): 03/03/2023

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: 08/27/2023
• Device Model Number: 1804350-15
• Device Catalogue Number: 1804350-15
• Device Lot Number: 1082341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2022
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2021
• 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