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

Model Number	1804275-15
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	06/22/2023
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.2017- improper or incorrect procedure or method, distal to stentna.
Event or Problem Description
It was reported that the procedure was to treat a moderately tortuous, heavily calcified left anterior descending artery.An unspecified guide catheter was advanced; however, visibility to the lesion was lost.Two xience stents were implanted.The 2.75x15mm xience skypoint stent delivery system (sds) was attempted to be advanced distally; however, met resistance with the previously implanted stents and anatomy.During removal of the sds, resistance was met with the anatomy, guiding catheter and previous implanted stents.It was noted that the stent stripped off the balloon when the proximal tip of the guide catheter pushed the stent off the balloon.The patient was sent to double bypass surgery.The stent was not retrieved during surgery and remains free floating in the anatomy.No additional information was provided.
Event or Problem Description
Subsequently, after the initial was filed it was noted that the two unspecified xience stents were a 2.25x28mm xience skypoint that was deployed in the diagonal and a 2.75x33mm xience skypoint that was deployed in the left anterior descending artery.
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.It should be noted that the xience skypoint everolimus eluting coronary stent system instruction for use states: when treating multiple lesions within the same vessel, stent the distal lesion prior to stenting the proximal lesion.Stenting in this order obviates the need to cross the proximal stent during placement of the distal stent and reduces the chance of damaging or dislodging the proximal stent.In this case, it does not appear the instruction for use (ifu) deviation related to placement distal to implanted stent caused the reported difficulties.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure.The reported patient effect of embolism is listed in the xience skypoint everolimus eluting coronary stent systems ifu as a known patient effect(s) of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: medical device problem code 2923 added.

• 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: 17334861
• Report Number: 2024168-2023-07617
• Device Sequence Number: 6477250
• Product Code: NIQ
• UDI-Device Identifier: 08717648233159
• UDI-Public: 08717648233159
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2023

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: 01/11/2026
• Device Model Number: 1804275-15
• Device Catalogue Number: 1804275-15
• Device Lot Number: 3011941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown