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

Model Number	1804300-15
Medical Device Problem Codes	Leak/Splash (1354); Difficult or Delayed Activation (2577); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.The investigation was unable to determine a conclusive cause for the reported leak.The reported difficulties of difficult or delayed activation, stent dislodgement and the patient effects of serious illness/injury/impairment and foreign body in patient appear to be related to operational context of the procedure.The investigation was unable to determine a conclusive cause for the reported leak as the device was not returned for analysis.It should be noted, there was no damage or leak noted to the stent delivery system (sds) during the inspection prior to use or during preparation for use which suggests a product quality issue did not contribute to the reported difficulties.The reported delayed activation appears to be related to operational context of the procedure as it is likely the reported device leak caused/contributed to the reported difficult or delayed activation.The device was removed; however, upon removal the stent was noted to be dislodged.The stent was found via cine and fluoroscopy partially deployed in the small branch of the ulnar artery.It is likely the partially expanded stent interacted with artery during removal causing the stent to dislodgement from the delivery system.The stent remains in the patient as no intervention was performed.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 a lesion in the left circumflex (lcx) artery.The 3.00x15mm xience skypoint stent delivery system (sds) was advanced to the target lesion; however, when attempting to deploy the stent the balloon was thought to have leak and may have ruptured.Pressure was increased; however, no atmospheres (atm) were reached to inflate the balloon and blood was noted to come back into the indeflator.The sds was removed from the patient; however, the stent was noted to not be the balloon.The guide catheter and guidewire were then removed from the patient.The stent was not in the guide catheter.Cine and fluoroscopy were performed up and down the radial access site to look for the dislodged stent and the xience stent was found to be partially deployed as both ends of the stent were noted to have expanded slightly in the small branch of the ulnar artery.No intervention was performed in the remove the dislodged stent.There was no adverse patient sequela.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: 16727386
• Report Number: 2024168-2023-03748
• Device Sequence Number: 8116537
• Product Code: NIQ
• UDI-Device Identifier: 08717648233234
• UDI-Public: 08717648233234
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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): 04/12/2023

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 Model Number: 1804300-15
• Device Catalogue Number: 1804300-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Sex: Unknown