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

Model Number	1804400-18
Medical Device Problem Codes	Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.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 during the intervention, while trying to advance the xience skypoint drug eluting coronary stent into a non-abbott stent that was previously implanted, the skypoint stent dislodged.Another balloon was used to snare the stent out of the anatomy.There was no reported adverse patient sequela or a clinically significant delay in procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported stent dislodgement and material deformation were confirmed.The reported difficulty to advance could not be replicated in a testing environment as it was related to operational context of the procedure.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 investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure as it is likely the device interacted with the previously implanted stent during the attempted crossing causing the reported difficulty to advance and subsequent material deformation of the un-implanted stent.During removal the device dislodged while partially inside of the guiding catheter.It is likely that the interaction with the previously implanted stent, difficult anatomy and/or guide catheter during removal caused the reported stent dislodgement.A balloon dilatation catheter was used to remove the dislodged stent without difficulty.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
Subsequent to the previous report, the following information was received: it was reported that the procedure was to treat a mildly calcified, mildly tortuous, 80% stenosed lesion in the ostial right coronary artery (rca).During the intervention, while positioning the 4x18mm xience skypoint drug eluting coronary stent (des) it became stuck on the previous non-abbott stent that was implanted approximately 4 months early.A strut of the xience des became flared from the back-and-forth movement of positioning.Device removal was attempted; however, the skypoint stent dislodged from the balloon when it was partially in the guiding catheter.A 1.5 balloon was placed distal to the stent, inflated and the stent was removed without difficulty.Dilatation was completed again with a 4.0 nc balloon and a 4x23mm xience stent was used to successfully complete the procedure.There was no reported adverse patient sequela or a clinically significant delay in procedure.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: 14320350
• Report Number: 2024168-2022-04979
• Device Sequence Number: 4516329
• Product Code: NIQ
• UDI-Device Identifier: 08717648233487
• UDI-Public: 08717648233487
• Combination Product (Y/N): Y
• Initial Reporter State: RI
• 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): 06/07/2022

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: 09/01/2023
• Device Model Number: 1804400-18
• Device Catalogue Number: 1804400-18
• Device Lot Number: 1083042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PREVIOUSLY IMPLANTED ONYX STENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 67 KG