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

Model Number	1804350-18
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.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 other incidents.The investigation was unable to determine a conclusive cause for the reported difficulties; however, potential factors which may contribute to difficulty advancing and removing the device in the guiding catheter include, but are not limited to, manufacturing, damage to the stent, damage to the guiding catheter, guiding catheter size selection or procedural technique (devices not properly supported or coaxially aligned).Stent dislodgement may be attributed to several factors including, but not limited to, improper or inadequate crimping at the time of manufacture, handling of the stent during preparation, and interaction with the anatomy, accessory devices and/or previously implanted stents.There was no damage 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.In this case, it is possible that the device interacted with accessory devices or was not properly supported / coaxially aligned during advancement / retraction, as resistance was reported, which may have contributed to the reported difficult to advance/position and difficult to remove (guide catheter resistance), ultimately causing the stent to dislodge in the guide catheter during removal; however, this cannot be confirmed.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 treat a heavily calcified, heavily tortuous, 90% stenosed lesion in the mid left anterior descending (lad) artery.A 3.5x18mm xience skypoint drug eluting stent (des) was advanced through a non-abbott extension catheter with resistance between the devices.The des was then removed from the anatomy with the extension catheter and when the extension catheter was removed, resistance was met with the des a second time and the stent was noted to be completely off of the delivery system balloon inside of the extension catheter.There was no adverse patient effect and no clinically significant delay in the procedure.A new xience des and a guide liner were used to successfully complete the 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: 15955592
• Report Number: 2024168-2022-12514
• Device Sequence Number: 7340997
• Product Code: NIQ
• UDI-Device Identifier: 08717648233401
• UDI-Public: 08717648233401
• 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): 12/09/2022

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: 06/10/2025
• Device Model Number: 1804350-18
• Device Catalogue Number: 1804350-18
• Device Lot Number: 2060241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2022
• 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: GUIDEPLUS EXTENSION CATHETER.
• Patient Sex: Unknown