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

Model Number	1804350-08
Medical Device Problem Codes	Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the production records and corrective or preventive actions (capa) was performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot of specific issue.The investigation determined the reported difficulties, treatment and patient effect appear to be related to the operational context of the procedure.It was reported that the stent delivery system interacted with the guide catheter during advancement.Factors that may contribute to difficulty advancing the sds through the catheter include, but are not limited to, inner diameter of the catheter, outer diameter of the sds, device support, buildup of procedural contaminants, challenging anatomy, user technique, and/or damage to the catheter or sds.In this case, it was noted that the catheter may have had a kink or insufficient inner diameter, likely contributing to the difficulty encountered during advancement.Additionally, manipulation of the sds, when it encountered difficulty, likely contributed to the reported stent dislodgement.The dislodged stent was implanted in the anatomy.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.
Event or Problem Description
It was reported that the procedure was performed to treat a very calcified lesion in the circumflex coronary artery.The 3.50 x 08mm xience skypoint stent delivery system (sds) was advanced through a non-abbott 7fr.Extra-backup catheter 3.5 guiding catheter, with resistance felt from a possible guiding catheter kink or a small lumen.The sds continued to be attempted to be advanced until it was decided to be removed.During withdrawal, the stent dislodged into the ostial of the circumflex coronary artery.An unsuccessful attempt was made to snare the stent, and the stent floated into the diagonal coronary artery.The stent was wired and two balloons from another manufacturer, a 1.5mm and a 2.0mm, were used to deploy the stent in the diagonal artery in healthy tissue.The circumflex artery was opted to not be treated as the patient had multiple diseased arteries, and an unspecified stent was successfully implanted in the left anterior descending coronary artery.There was no adverse patient sequalae.No additional information 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: 19646712
• Report Number: 2024168-2024-07865
• Device Sequence Number: 7368323
• Product Code: NIQ
• UDI-Device Identifier: 08717648233371
• UDI-Public: (01)08717648233371(17)260711(10)3071441
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/01/2024

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 Expiration Date: 07/11/2026
• Device Model Number: 1804350-08
• Device Catalogue Number: 1804350-08
• Device Lot Number: 3071441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2023
• 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: NON-ABBOTT 7FR. EXTRA-BACKUP CATHETER 3.5 GUIDING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown