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

Model Number	1804350-18
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device.The reported material deformation (stent damage) was confirmed.The reported failure to advance could not be replicated in a testing environment as it was related to operational context of the procedure.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 identified no similar incidents from this lot.The investigation determined the reported failure to advance appears to be related to the operational context of the procedure as it is likely that the sds interacted with the lesion during advancement resulting in the reported failure to advance and subsequent stent dislodgement/dislocated (observed during returned device analysis) and material deformation.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 90% stenosed lesion in circumflex artery with calcification and tortuosity.The 3.50x18mm xience skypoint stent delivery system (sds) was advanced to the target lesion; however, the stent met with resistance with the heavily calcified lesion and failed to cross.When the sds was removed from anatomy and the stent struts were noted to be flared.Additional pre-dilatation was performed and a new xience skypoint stent was used to complete the procedure.No additional information was provided return device analysis found the proximal end of the stent implant was located 1mm distal from its original crimped position as the stent implant had moved distally on the balloon.

• 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: 17278611
• Report Number: 2024168-2023-07189
• Device Sequence Number: 12033479
• Product Code: NIQ
• UDI-Device Identifier: 08717648233401
• UDI-Public: 08717648233401
• Combination Product (Y/N): Y
• 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
• Report Date (Section B): 07/07/2023

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: 01/08/2026
• Device Model Number: 1804350-18
• Device Catalogue Number: 1804350-18
• Device Lot Number: 3012341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2023
• 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