MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number	1550225-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Dyspnea (1816); Pain (1994); Dizziness (2194)
Date of Event	12/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.A review of the lot history record was not performed because the lot number was not reported.The reported patient effects of angina and pain are listed in the xience sierra, everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
Event or Problem Description
It was reported that the patient had three xience sierra stents (2.25x23 mm (x2), 2.50x12 mm) implanted in an unspecified coronary artery on (b)(6) 2018 and has not been able to sleep, feeling dizzy and light headed, shortness of breath, chest pain and access site tenderness in the femoral artery since the procedure.The patient does not have any known allergies to metal.On (b)(6) 2018 the patient went to the emergency room and echocardiogram was performed.No further intervention was performed as the pain was reported to be likely from healing from the stents being implanted.The patient was given nitroglycerin for the chest pain and discharged from the hospital on (b)(6) 2018.As of (b)(6) 2018, the patient is feeling better but still experiencing shortness of breath.No additional information was provided.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8175253
• Report Number: 2024168-2018-09803
• Device Sequence Number: 1446720
• Product Code: NIQ
• UDI-Device Identifier: 08717648227035
• UDI-Public: 08717648227035
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/18/2018

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 Catalogue Number: 1550225-23
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 12/18/2018
• 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: STENT: XIENCE SIERRA (2.25X23 MM, 2.50X12 MM)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 82