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

Model Number	1804300-33
Medical Device Problem Codes	Entrapment of Device (1212); 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	11/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat the proximal left anterior descending (lad) coronary artery with moderate calcification and moderate tortuosity.The 3.0x33 mm xience skypoint stent delivery system (sds) was being advanced when the engagement of the guiding catheter became unstable and resistance was noted with the guiding catheter during advancement.While pushing and pulling the sds around the guiding catheter with resistance, the stent hit the edge of the guiding catheter causing stent deformation and displacement on the balloon.The stent remained on the balloon and the entire sds was ultimately retrieved via snare, using a femoral approach.A non-abbott stent was used to complete the procedure.There were no adverse patient sequela 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
The device was not returned for analysis.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.A conclusive cause for the reported difficulties cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.It was reported that the stent delivery system (sds) met resistance with a guiding catheter, resulting in the stent became deformed and displaced on the balloon.Factors that may contribute to difficulty advancing the sds through the guiding catheter include, but are not limited to, inner diameter of the catheter, system profile, guidewire movement (im collapse), inadequate deliverability, or challenging anatomy.Based on the information provided and because the device was not returned for analysis, it is unknown what may have caused the reported difficulties during advancement.In addition, it was reported that the sds became deformed and displaced.In this case, it is possible the manipulation of the sds, when resistance was met, contributed to the reported material deformation and device dislodged or dislocated.Additionally, it is likely that the interaction with the guiding catheter contributed to the entrapment.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.

• 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: 20855499
• Report Number: 2024168-2024-14314
• Device Sequence Number: 15661276
• Product Code: NIQ
• UDI-Device Identifier: 08717648233272
• UDI-Public: (01)08717648233272(17)261112(10)3111641
• 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,Followup
• Report Date (Section B): 01/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1804300-33
• Device Catalogue Number: 1804300-33
• Device Lot Number: 3111641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2023
• 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: UNSPECIFIED GUIDING CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown