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

Catalog Number	1804350-33
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/21/2023
Type of Reportable Event	Serious Injury
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 did not indicate a lot specific quality issue.The investigation determined the reported difficulties and subsequent foreign body in patient 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.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the right coronary artery (rca).The patient presented with a st elevation myocardial infarction (stemi).Using right femoral access, the 3.5x33mm xience skypoint stent delivery system (sds) was attempted to be advanced to the target lesion; however, failed to cross due to resistance with the anatomy.Therefore, the sds was removed and resistance was also noted due to the anatomy.When the sds was removed, the stent was noted to have become dislodged from the balloon.The guide wire (gw) and guideliner were removed; however, the stent was not located on the gw or in the guideliner.The stent was confirmed to be not be in the cardio; however, the stent was not able to be located.Another same size xience skypoint stent was implanted.There was no adverse patient sequela and no clinically significant delay in procedure reported.No additional information was provided.

• 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: 17934156
• Report Number: 2024168-2023-11328
• Device Sequence Number: 6308540
• Product Code: NIQ
• UDI-Device Identifier: 08717648233432
• UDI-Public: 08717648233432
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 10/13/2023

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: 04/24/2026
• Device Catalogue Number: 1804350-33
• Device Lot Number: 3050241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6 FR SHEATH; AR1 GUIDE CATHETER
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Sex: Male