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

Model Number	1550275-38
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994)
Date of Event	12/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.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 effects of hypersensitivity and pain are listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use (eifu) as known patient effects 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 reported 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 of the device.The additional xience sierra stent, referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that on (b)(6) 2019, two xience sierra stents were implanted in an unspecified coronary artery.Since the procedure, the patient has experienced pain in her mouth, she suspected as an allergic reaction.The patient went to the physician regarding this issue and the physician recommended benadryl to see if that would help.There was no additional hospitalization and there was no device issue reported.There was no additional adverse patient sequela.No additional information was provided regarding this issue.

• Brand Name: XIENCE SIERRA
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9829931
• Report Number: 2024168-2020-02401
• Device Sequence Number: 10944437
• Product Code: NIQ
• UDI-Device Identifier: 08717648227226
• UDI-Public: 08717648227226
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2020

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: 09/01/2020
• Device Model Number: 1550275-38
• Device Catalogue Number: 1550275-38
• Device Lot Number: 9082241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: XIENCE SIERRA STENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Weight: 64