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

Model Number	1804250-33
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	11/30/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that the procedure on (b)(6) 2024 was to treat the right coronary artery (rca) with no calcification and mild tortuosity.The lesion was confirmed with intravascular ultrasound (ivus), pre-dilated with a non-compliant balloon and the 3.0 x 38 mm xience skypoint stent was implanted.The stent was post-dilated and the procedure was completed with no complications.On (b)(6) 2024 the patient returned for a planned procedure to treat the left anterior descending (lad) coronary artery with moderate calcification and mild tortuosity.The lesion was confirmed with fractional flow reserve (ffr) and optical coherence tomography (oct).Intravascular lithotripsy (ivl) was performed due to the moderate calcification and the 2.5 x 33 mm xience skypoint stent was implanted and post-dilated.The procedure was successful with no complications.The patient did not visit the outpatient clinic for the 1 year follow up and it was found that the patient expired on (b)(6) 2024 due to an unknown cause.The medical institution's opinion is that the event is unrelated to the study; however, the death is potentially related to the stents, per the physician.No additional information was provided.
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 patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effect of death is listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.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 UNK ; EI UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 21730934
• Report Number: 2024168-2025-03244
• Device Sequence Number: 8734944
• Product Code: NIQ
• UDI-Device Identifier: 08717648233111
• UDI-Public: (01)08717648233111(17)241124(10)111104A
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/24/2024
• Device Model Number: 1804250-33
• Device Catalogue Number: 1804250-33
• Device Lot Number: 111104A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2021
• 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: 3.0X38 MM XIENCE SKYPOINT STENT.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 76 YR
• Patient Sex: Unknown
• Patient Weight: 61 KG