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

Model Number	1804250-15
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that prior to use of the 2.50x15mm xience skypoint stent delivery system (sds) the protective sheath was removed without resistance.The catheter was soaked in saline and the device was prepped (air aspiration) inside the anatomy.The procedure was to treat a 90% stenosed lesion in the distal left circumflex artery with heavy calcification and heavy tortuosity.The sds was advanced to the target lesion with difficulty due to the anatomy.However, the balloon burst during the first inflation after 20 seconds at 12 atmospheres (atm).The sds was removed from the patient.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information has been 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.It was reported xience sypoint stent delivery system (sds) was prepped inside the anatomy.It should be noted that the xience skypoint everolimus eluting coronary stent system instruction for use (ifu) lists delivery system preparation to be performed prior to delivery procedure.In this case, it is unknown if the instruction for use (ifu) deviation related to incorrect stent preparation may have contributed to the reported event.The investigation determined the reported difficulty to advance and material deformation appear to be related to circumstances of the procedure.The investigation was unable to determine a conclusive cause for the reported material rupture.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
Subsequent to initial report, the following information was reported: it was reported that the stent edge may have become flared.No additional information has been 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: 15459785
• Report Number: 2024168-2022-09908
• Device Sequence Number: 5569864
• Product Code: NIQ
• UDI-Device Identifier: 08717648233074
• UDI-Public: 08717648233074
• 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): 11/14/2022

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: 03/15/2024
• Device Model Number: 1804250-15
• Device Catalogue Number: 1804250-15
• Device Lot Number: 1031041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2022
• Supplement Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 09/20/2022
• Supplement Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2021
• 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
• Patient Sex: Unknown