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

Catalog Number	1804300-28
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Angina (1710); Foreign Body In Patient (2687)
Date of Event	12/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.Attachment: medwatch report #0300890000-2023-8010.
Event or Problem Description
This event was reported thru the receipt of a medwatch which stated: describe the event or problem: per cardiac catheterization note - i attempted to cross the blockage with xience skypoint¿ stent however it would not cross.While it was being retrieved, stent came off the balloon in the proximal circumflex.There was still thrombolysis in myocardial infarction (timi) 3 flow however at this point.I focused to cross the stent struts against the vessel wall.Multiple wires, balloon and support catheters were used including pilot, fielder, run-through, whisper along with turnpike versus small support balloons but i could not cross beyond this segment.Patient was having active pain for which i decided to stabilize left main into left anterior descending artery (lad).3.5 x 30 onyx stent was then deployed from mid left main into proximal lad.Same stent balloon was used for post dilation of this stented segment.Further postdilation was done using 4.0 noncompliant balloon in left main and proximal lad.I attempted to rewire the circumflex with the stent struts, and i was able to get through the proximal stent where i had a 2.0 balloon to open up stent struts.I could still not go beyond mid circumflex where stent had dislodged.I decided to accept this result as further attempts were likely going to be unsuccessful.Impella was weaned off.Brilinta had been loaded and will be continued.Impella was removed.Preclose's were deployed and patent hemostasis was achieved.The patient tolerated the procedure well and left the cardiac catheterization laboratory pain-free and stable condition where he was taken back to an electrocardiographic a monitored site.No additional information was provided.
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 identified no similar incidents from this lot.The reported patient effect of angina is listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure.Additionally, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.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: 18865876
• Report Number: 2024168-2024-02990
• Device Sequence Number: 3337929
• Product Code: NIQ
• UDI-Device Identifier: 08717648233265
• UDI-Public: (01)08717648233265(17)241009(10)2101341
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2024

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: 10/09/2024
• Device Catalogue Number: 1804300-28
• Device Lot Number: 2101341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2024
• Supplement Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown