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

Model Number 1550300-23

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 07/13/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis as the stent remains implanted.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of hypersensitivity/allergic reaction is listed in the xience sierra, everolimus eluting coronary stent systems, as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the patient has a history of shortness of breath with exertion.A cta (computed tomography angiography) was performed which found some occlusion with hemodynamic significance.On (b)(6) 2021 the patient underwent a percutaneous coronary intervention in the mid (lad) left anterior descending coronary artery.The 3.0x23 mm xience sierra stent was implanted in the mid lad.She has a nickel allergy but did not disclose this allergy to the hospital and physician until after the stent was implanted.She was given prednisone medication prior to the procedure as she is allergic to many things such as iodine, lidocaine, contrast, latex, pollen, and animals.When she took the prednisone on (b)(6) 2021, her blood sugar went to the 340s, so she reduced the prednisone dose.The next day, on (b)(6) 2021, she started feeling flushed and itchy on her face and trunk.This is a common reaction for her when she is allergic to something.On 07/15/2021 the itching on her trunk had resolved, but her face was still flushed.The flushed face is not as intense though.No additional information was provided.

• 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: 12228788
• MDR Text Key: 263559162
• Report Number: 2024168-2021-06492
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227271
• UDI-Public: 08717648227271
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2023
• Device Model Number: 1550300-23
• Device Catalogue Number: 1550300-23
• Device Lot Number: 0091741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 97