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

Model Number	1804300-38
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.Na.
Event or Problem Description
It was reported that the procedure was to a lesion in the mid right coronary artery (mrca) with moderate calcification.The 3.00x38mm xience skypoint stent delivery system (sds) was attempted to be advanced to the target lesion; however, failed to advance and the stent struts were noted to be flared.Therefore, the sds was attempted to be removed; however, the sds could not be inserted into the guide catheter.The sds had to be removed with the guidewire and guide catheter as a single unit.There was no adverse patient effect and clinically significant delay reported in the procedure.The stent was deployed after removal to evaluate the stent damage post procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and functional inspection was performed on the returned device.The reported material deformation was confirmed.The reported failure to advance and difficult to remove could not be evaluated as the exact anatomical conditions and accessory devices encountered by the device used during the procedure could not be replicated in the test laboratory.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 the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 16905667
• Report Number: 2024168-2023-05007
• Device Sequence Number: 5561969
• Product Code: NIQ
• UDI-Device Identifier: 08717648233289
• UDI-Public: 08717648233289
• 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,Followup
• Report Date (Section B): 06/19/2023

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: 10/17/2023
• Device Model Number: 1804300-38
• Device Catalogue Number: 1804300-38
• Device Lot Number: 1100841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LAUNCHER AL 1 GUIDE CATHETER.
• Patient Sex: Unknown