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

Model Number 1550400-28

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

Patient Problems Arrhythmia (1721); Hypersensitivity/Allergic reaction (1907)

Event Date 03/24/2019

Event Type  Injury  

Event Description

It was reported the 4.0x28mm xience sierra stent was implanted in the left anterior descending on (b)(6) 2019, to treat a st-elevation myocardial infarction stemi.Soon after the procedure, sometime in (b)(6) 2019, (date not provided), the patient was re-hospitalized with strong heart palpitations, no treatment was performed.The patient continued with palpitations and continued to return to the hospital 7-8 times.No treatment was performed.Berlinta was continued to be taken for more than two years after the procedure.A cardiac catheterization was performed about a year ago; the stent appeared clear, with no obstruction.The patient obtained a second opinion with a new cardiologist.The cardiologist instructed the patient to stop taking berlinta and to take aspirin.Recently the patient had a right foot wound in which surgical tape was used.The tape caused a second-degree burn to the foot.An allergy test was performed.The results came back the patient is allergic to nickel sulfate hexahydrate, potassium dichromate, and chrome/chromium metal.The patient is concerned that the palpitations he has been experiencing have been due to the sierra stent, because he is allergic to chromium metal.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.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; therefore, no product-related corrective action will be implemented in this case.Estimated date of event: (b)(6) 2019.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING 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: 13930326
• MDR Text Key: 288044244
• Report Number: 2024168-2022-03236
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227523
• UDI-Public: 08717648227523
• 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: Other
• Type of Report: Initial
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2019
• Device Model Number: 1550400-28
• Device Catalogue Number: 1550400-28
• Device Lot Number: 8062641
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2018
• 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): Hospitalization
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 78 KG