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

Model Number	1804350-12
Medical Device Problem Codes	Device Damaged by Another Device (2915); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The stent will not be returned for evaluation.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 on (b)(6) 2021, the 3.5x12mm xience skypoint stent was successfully implanted to treat the ostium of the circumflex artery.On (b)(6) 2021, the patient returned for a procedure to treat the left anterior descending (lad) coronary artery.During the advancement of an unspecified guidewire to the target lesion, the guide wire became stuck underneath the skypoint stent.When attempting to pull out the guide wire without excessive force, the stent was removed [explanted] from the anatomy with the guide wire.The procedure for the lad continued.There was no further treatment for the circumflex artery.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the electronic lot history record (elhr) and similar incident query for this product was not performed because the lot number was not reported and the product was not returned for analysis.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the previously implanted stent causing the reported difficulty to advance and subsequent device damaged by another.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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
• MDR Report Key: 12280228
• Report Number: 2024168-2021-06845
• Device Sequence Number: 11722777
• Product Code: NIQ
• UDI-Device Identifier: 08717648233388
• UDI-Public: 08717648233388
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2021

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 Model Number: 1804350-12
• Device Catalogue Number: 1804350-12
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 08/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1