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

Model Number	1804250-18
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	12/16/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the procedure was to treat an unspecified lesion.The 2.5x18 mm xience skypoint stent delivery system (sds) failed to advance due to it being stuck with an unspecified guide wire.A 2.5x23 mm xience skypoint sds was used to complete the procedure.There were no reported patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and dimensional inspection were performed on the returned device.The reported difficult to advance and difficult to remove could not be tested due to the device condition.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported difficulties.Factors that may contribute to difficulty advancing/removing the stent delivery system (sds) over the guide wire include, but are not limited to, procedural contaminant buildup in the guide wire lumen, inner diameter of the guide wire lumen, outer diameter of the guide wire, and/or damage to the guide wire lumen or guide wire.In this case, it is unknown what may have caused or contributed to the reported difficulty to advance/remove.Additionally, it is possible that manipulation of the sds during its interaction with the guide wire contributed to the damaged inner member, hypotube, and balloon noted during return analysis; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.D4b; updated the serial number from na to (b)(6).
Event or Problem Description
It was reported that the procedure was to treat an unspecified lesion.The 2.5x18 mm xience skypoint stent delivery system (sds) failed to advance due to it being stuck with an unspecified guide wire.A 2.5x23 mm xience skypoint sds was used to complete the procedure.There were no reported patient effects and there was no clinically significant delay in the procedure.No additional information was provided.Subsequent to the initially filed report, the following information was provided: the sds became stuck on the guide wire prior to being inserted into the guiding catheter.There were no adverse patient effects and the sds was removed independently.No additional information was provided.

• 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: 16117526
• Report Number: 2024168-2023-00263
• Device Sequence Number: 17859332
• Product Code: NIQ
• UDI-Device Identifier: 08717648233081
• UDI-Public: 08717648233081
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2023

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: 10/04/2023
• Device Model Number: 1804250-18
• Device Catalogue Number: 1804250-18
• Device Lot Number: 0092341
• 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: 12/16/2022
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2020
• 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: UNSPECIFIED GUIDE WIRE
• Patient Sex: Unknown