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

Catalog Number	1550400-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Angina (1710)
Date of Event	04/19/2019
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 incident information was reviewed; however, the product was not returned to abbott vascular for analysis.The reported patient effect(s) of angina and additional therapy are listed in the xience sierra everolimus eluting coronary stent systems instructions for use, as known patient effect(s) of coronary stenting procedures.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.There was no reported device malfunction.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.The hospitalization and treatment appear 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.
Event or Problem Description
It was reported that a 4.0 x 12 mm xience sierra stent was implanted on(b)(6) 2019.On (b)(6) 2019, the patient was re-admitted with angina and other unspecified cardio vascular symptoms.Unspecified treatment was administered to the patient.Final patient outcome is reportedly unknown.No additional information was provided.
Additional Manufacturer Narrative
Internal file number: (b)(4).

• 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: 8701954
• Report Number: 2024168-2019-04730
• Device Sequence Number: 13864054
• Product Code: NIQ
• UDI-Device Identifier: 08717648227486
• UDI-Public: 08717648227486
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: health professional,other
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2019

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: 10/22/2019
• Device Catalogue Number: 1550400-12
• Device Lot Number: 8101641
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/14/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 101