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

Model Number	1804400-23
Medical Device Problem Codes	Off-Label Use (1494); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); Embolism/Embolus (4438)
Date of Event	09/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: medical device problem code 1494 - incorrect anatomy.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the tibial peroneal trunk.The 4x23mm xience skypoint stent delivery system (sds) was being advanced to the target lesion, when the stent was noted to have partially moved from the markers.Therefore, the sds was attempted to be removed when the stent became completely dislodged from the delivery system and embolized in the distal vessel.A snare was used to attempt to remove the stent, but was unsuccessful.A balloon was then advanced and used to embed the stent in the distal vessel.There was no adverse patient sequela.No procedure was then aborted and no stent was implanted at the target lesion.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.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 information provided, a definitive cause for the reported issue could not be determined.It was reported that the procedure was to treat a lesion in the tibial peroneal trunk.It should be noted that the xience skypoint instructions for use, (ifu) states: the xience skypoint stent system is indicated for improving coronary artery luminal diameter in patients, including those with diabetes, mellitus, with symptomatic heart disease due to de novo native coronary artery lesion.It is unknown if the ifu deviation directly caused or contributed to the reported event.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.The reported device embedded and unexpected medical intervention appears to be related to operational context of the procedure.Based on the results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 20303914
• Report Number: 2024168-2024-11293
• Device Sequence Number: 8883349
• Product Code: NIQ
• UDI-Device Identifier: 08717648233494
• UDI-Public: (01)08717648233494(17)270507(10)4051541
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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): 10/14/2024

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 Model Number: 1804400-23
• Device Catalogue Number: 1804400-23
• Device Lot Number: 4051541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown