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

Catalog Number	1804250-33
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.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 did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that resistance was met with the heavily calcified and 99% stenosed anatomy resulting in the reported failure to advance and the reported difficult to remove.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat a de novo lesion located in the mid-left anterior descending coronary artery that was heavily calcified and 99% stenosed.The xience skypoint stent delivery system failed to cross and there was resistance during removal with the anatomy.The procedure was completed with another device.There were no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The xience skypoint is currently not commercially available in the us; however, it is similar to a device sold in the us.

• 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: 11121127
• Report Number: 2024168-2021-00111
• Device Sequence Number: 631040
• Product Code: NIQ
• UDI-Device Identifier: 08717648233111
• UDI-Public: 08717648233111
• 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): 01/05/2021

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: 09/22/2023
• Device Catalogue Number: 1804250-33
• Device Lot Number: 0091641
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1