MAUDE Adverse Event Report: ABBOTT VASCULAR INC. XIENCE SKYPOINT¿; CORONARY DRUG-ELUTING STENT

Model Number	1804300-12
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat the ramus coronary artery with no calcification or tortuosity.A non-abbott guide wire was placed for right radial access.An unspecified stent had previously been placed in the ostial left anterior descending (lad) coronary artery and then the 3.0x12 mm xience skypoint stent delivery system (sds) was advanced to the ostial ramus and implanted.The delivery system balloon remained and a 4.0x8 mm balloon from another manufacturer was advanced to the lad for kissing balloon technique of the lad/ramus.It was difficult to get the balloon to the intended location so the physician attempted to pull back the xience skypoint delivery system.There was resistance and the physician tugged a bit and all of the devices were entangled and were removed as a single unit along with 2 non-abbott guide wires in the 6fr guiding catheter.During this the shaft of the xience skypoint sds separated but the separated portion was simply withdrawn with the other devices.Nothing was left in the patient.A new guiding catheter and more balloons were used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.Material separation was confirmed.The reported difficult to advance and removed could not be confirmed due to the returned condition of the device.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported issue appears to be related to circumstances of the procedure.It was reported that the stent delivery system (sds) encountered resistance with accessory devices during advancement and removal, and subsequently separated.The analysis of the returned device confirmed the reported material separation.In this case, it is likely that the sds entangled with the accessory devices contributed reported difficulties to advance and removed.Additionally, manipulation of the stent delivery system when the resistance was encountered likely contributed to the reported material separation.The analysis noted the guidewire exit notch was torn and stretched.This type of damage is consistent with manipulation against resistance.It was reported that the physician applied force to the stent delivery system (sds) during removal.During this the shaft of the sds separated but the separated portion was simply withdrawn with the other devices.It should be noted that the xience skypoint instructions for use states: applying excessive force to the delivery system can potentially result in loss of or damage to the stent and/or delivery system components.In this case, it appears that the deviation was a responsible clinical response to the encountered difficulties.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.B5: describe event or problem: updated.H6: medical device problem code 2017: excessive force.
Event or Problem Description
Subsequent to the initially filed report it was reported that there was resistance in the guiding catheter when the 4.0x8 mm balloon was advanced.When resistance was felt during removal, force was applied.No additional information was provided.

• Brand Name: XIENCE SKYPOINT¿
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 20836894
• Report Number: 2024168-2024-14226
• Device Sequence Number: 8502036
• Product Code: NIQ
• UDI-Device Identifier: 08717648233227
• UDI-Public: (01)08717648233227(17)270623(10)4070141
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• 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): 01/08/2025

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: 1804300-12
• Device Catalogue Number: 1804300-12
• Device Lot Number: 4070141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• 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: IKARI LEFT GUIDE WIRE
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 94 KG