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

Model Number	1804400-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Fatigue (1849); Headache (1880); Hypersensitivity/Allergic reaction (1907); Rash (2033)
Date of Event	08/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.Electronic lot history record (elhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other similar incidents from this lot.The reported patient effect(s) of hypersensitivity and angina is listed in the xience skypoint everolimus eluting coronary stent system instructions for use as a known adverse event which may be associated with pci treatment procedures and the use of a coronary stent use in native coronary arteries.A conclusive cause for the reported angina, fatigue, headache, hypersensitivity/allergic reaction, and rash, and the relationship to the product, if any, cannot be determined.The treatment(s) appears to be related to the operational context of the procedure.Based on the reported information and 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.
Event or Problem Description
It was reported that the procedure was treat a lesion in the mid right coronary artery (rca).The xience skypoint stent was implanted; however, patient developed an allergic reaction possibly to the implanted stent 2 days after implantation.Currently, symptoms are: itching, needle sensation, wrinkles, shaking, back of eyes hurt, dry mouth, tightness still in arm and chest, chills, sweats, fatigue, anxiety/depression, stress, and memory problems.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: 19763890
• Report Number: 2024168-2024-08461
• Device Sequence Number: 8778213
• Product Code: NIQ
• UDI-Device Identifier: 08717648233470
• UDI-Public: (01)08717648233470(17)251211(10)2122041
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/17/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/11/2025
• Device Model Number: 1804400-15
• Device Catalogue Number: 1804400-15
• Device Lot Number: 2122041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2022
• 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: Other
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 129 KG