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

Model Number	1804400-18
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.The reported difficult to advance and difficulty to remove could not be confirmed due to the condition the device was received for evaluation.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 appear to be related to circumstances of the procedure as it is likely the device interacted with the guidewire during advancement and removal causing the reported difficulties.It should be noted the guide wire was returned with multiple bends, damage to the polymer coating and scraping throughout the teflon coating.The noted guide wire damage as well as possible blood and other procedural contaminants likely caused the reported difficulty advancing and/or removal of the device from the guide wire.There is no indication of a product quality issue with respect to manufacture, design or labeling.The whisper extra support guide wire referenced will be filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was performed to treat a target lesion in the moderately tortuous right coronary artery (rca).The 4.0 x 18 mm xience skypoint stent delivery system was advanced over the whisper extra support guide wire.Resistance was noted during advancement, and the stent delivery system became stuck.The stent delivery system could not be removed from the guide wire.Both devices were removed as a single unit.There was no adverse patient effect and no clinically significant delay.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
• MDR Report Key: 12351285
• Report Number: 2024168-2021-07368
• Device Sequence Number: 14703059
• Product Code: NIQ
• UDI-Device Identifier: 08717648233487
• UDI-Public: 08717648233487
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/20/2021

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 Expiration Date: 03/21/2023
• Device Model Number: 1804400-18
• Device Catalogue Number: 1804400-18
• Device Lot Number: 1031641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1