MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1804275-28

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Date 02/23/2024

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.Lot history record (lhr) and exception reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no similar incidents from this lot.The reported patient effect of hypersensitivity/allergic reaction is listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was performed in the left anterior descending (lad) artery.The 2.75x28mm xience skypoint stent was implanted on (b)(6) 2024.Patient began taking 3 cardiologist-prescribed drugs: (1) brilinta on (b)(6) 2024 - 2 90mg tablets daily; (2) ezetimibe on (b)(6) 2024 - 1 10mg tablet daily; and (3) metoprolol er succinate 25 mg tablets on (b)(6) 2024 - 1 25mg tablet daily.On (b)(6) 2024, the patient developed a rash on the arms and legs and intense itching began.With physician's guidance, patient tried eliminating certain drugs, received steroid treatments, both injections and prednisone pills.The rashes are still persisting and intense itching on both arms and both legs.In the physician's opinion, one of the three new drugs is likely causing or contributing to the rash and itchiness.The patient is not aware of having any allergies to medications or metals and has an appointment with the allergist on (b)(6) 2024.No additional information was provided.

Manufacturer Narrative

Section a: patient information: subsequent to filing the initial report, patient information was provided.

• Brand Name: XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 19096635
• MDR Text Key: 340029149
• Report Number: 2024168-2024-04609
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233180
• UDI-Public: (01)08717648233180(17)240720(10)107144B
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1804275-28
• Device Lot Number: 107144B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White