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

Catalog Number	1804350-12
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	04/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no similar complaints from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure, as it is likely the xience skypoint interacted with accessory devices (guide catheter), during advancement, as resistance was noted, causing the reported difficult to advance/position and material deformation.Further manipulation of the device inside the guide catheter likely caused the reported stent dislodgement.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported the procedure was to treat a mildly calcified and moderately tortuous lesion in the mid right coronary artery.During advancement of the 3.50x12mm rx xience skypoint stent delivery system (sds) through the 6f guiding catheter (gc) resistance was met and the stent became deformed due to the stent being pushed and pulled around the gc.The stent was mislocated on the balloon.The sds was withdrawn from the gc and the procedure was completed using a non-abbott stent.There was no clinically significant delay in the procedure and no adverse patient effects.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: 19351953
• Report Number: 2024168-2024-06083
• Device Sequence Number: 7232282
• Product Code: NIQ
• UDI-Device Identifier: 08717648233388
• UDI-Public: (01)08717648233388(17)261018(10)3102441
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2024

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 Catalogue Number: 1804350-12
• Device Lot Number: 3102441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2023
• 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: 6F GUIDING CATHETER
• Patient Sex: Unknown