MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE PRO EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number UNK RX XIENCE PRO

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

Patient Problems Aneurysm (1708); Angina (1710); Hypersensitivity/Allergic reaction (1907)

Event Date 01/17/2024

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported the xience pro stent was implanted on (b)(6) 2023.On (b)(6) 2024, optical coherence tomography showed formation of multiple aneurysms around the stent.The doctor is concerned if this could be linked to a rare allergy reaction to either the drug or the polymer.The patient has had no other symptoms and is doing fine.No additional information was provided.

Event Description

Subsequent to the initial report, the following information was provided: the xience pro stent was implanted on 7/28/2023.The patient returned on 1/17/2024 for a planned follow-up visit of the index procedure, to check on the initial left anterior descending (lad) artery after percutaneous coronary intervention (pci), and to perform pci of the diseased circumflex (cx) as a stages procedure.The patient had ongoing angina pectoris after the initial lad pci.This was not an acute readmission but a planned review and staged procedure to the cx.The aneurysms around the implanted stent in the lad was discovered during this follow up procedure.Angio showed pockets of contrast appearing outside of the vessel contours and optical coherence tomography (oct) was performed to confirm the formation of aneurysms around the stent.Due to this finding, the cx was not treated in fear of a potential allergic reaction to the stent metal, polymer, or drug.The patient was discharged with adjusted (higher doses) anginal medications on 1/18/2024 and is scheduled to return for a re-angio and oct.The patient is still in need for pci of the cx but might have to consider coronary artery bypass graft if this is true allergy to stents.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the electronic lot history record (elhr) for this product was not performed because the part and lot numbers were not reported and the product was not returned for analysis.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.The reported patient effect(s) of aneurysm, angina and hypersensitivity are listed in the xience pro everolimus eluting coronary stent systems instructions for use as a known patient effect(s) 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.D4: the udi is unknown due to the part/lot number was not provided.A2/a3: patient info updated.B2: not hospitalized-other serious.B3: date of event updated: 1/17/2024.B5 - describe event or problem updated.B7: add relevant med history updated.D6a: implant date: 7/28/2023 updated.E1: phone number updated.H6: device code removed 4607, added pc 1710 and pc 4644.

• Brand Name: XIENCE PRO EVEROLIMUS ELUTING RX CORONARY STENT 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: 18664233
• MDR Text Key: 334832483
• Report Number: 2024168-2024-01565
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK RX XIENCE PRO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male