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

Model Number	1804300-12
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	11/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a 90% stenosed de novo lesion in the 1st obtuse marginal artery with mild calcification and moderate tortuosity.A 2.50x23mm xience skypoint stent was implanted; however, the stent was not long enough for the lesion, so a 3.00x12mm xience skypoint stent delivery system (sds) was advanced, but met resistance due to the tortuosity of the vessel.The device was re-positioned and attempted again to advance to the lesion.A false lumen may have been created and the vessel appeared damaged.The 3.0 x 12 mm xience skypoint was removed from the patient.Upon removal, the distal edge stent struts were noted to be flared and the proximal stent was noted to be deformed.There was no clinically significant delay reported in the procedure.No further treatment to the patient was provided.No additional information was provided.
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.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported failure to advance and difficult to remove could not be tested as they were based on operational context.The reported material deformation and deformation due to compressive stress was confirmed.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 determined the reported difficulties and subsequent treatment appear to be related to the operational context of the procedure; however, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.In this case, it is likely that the stent delivery system interacted with the patient¿s mildly calcified, moderately tortuous, and 90% stenosed lesion during advancement, as resistance was noted, resulting in the reported failure to advance.Manipulation of the device during its interaction with the lesion likely resulted in the reported stent material deformation and hypotube deformation due to compressive stress.Additionally, it was reported that the device encountered difficulty during removal with the guide catheter, likely due to the damaged stent.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.

• 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: 15926322
• Report Number: 2024168-2022-12278
• Device Sequence Number: 5116103
• Product Code: NIQ
• UDI-Device Identifier: 08717648233227
• UDI-Public: 08717648233227
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/17/2024
• Device Model Number: 1804300-12
• Device Catalogue Number: 1804300-12
• Device Lot Number: 1011241
• 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: 11/15/2022
• Supplement Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2021
• 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: 2.50X23MM XIENCE SKYPOINT STENT; LAUNCHER 7F SL4 GC
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown