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

Catalog Number	1804225-28
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The xience skypoint is currently not commercially available in the us; however, it is similar to a device sold in the us.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified, moderately tortuous, 90% stenosed, de novo, distal left anterior descending coronary artery (dlad) lesion.A 2.25x28 xience skypoint drug eluting stent (des), was advanced against resistance and failed to cross the lesion.When the device was removed, it was noted that the distal edge of the stent was flared, and the stent had shifted on the balloon.There was no adverse patient effect and no clinically significant delay in the procedure.A non-abbott device was used to successfully complete the procedure.No additional information was provided.
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.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.It is likely the device interacted with the heavily calcified, moderately tortuous, 90% stenosed lesion during advancement, as resistance was noted, resulting in the reported failure to advance and material deformation.Further interaction with the challenging anatomy during advancement/retraction of the device likely contributed to the reported stent movement/dislodgement.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

• 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
• MDR Report Key: 11113371
• Report Number: 2024168-2021-00045
• Device Sequence Number: 3923056
• Product Code: NIQ
• UDI-Device Identifier: 08717648233029
• UDI-Public: 08717648233029
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2021

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: 09/01/2023
• Device Catalogue Number: 1804225-28
• Device Lot Number: 0082641
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 01/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SYNERGY XD 2.25*24.