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

Catalog Number	1550275-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Cardiac Enzyme Elevation (1838); Respiratory Failure (2484)
Date of Event	04/27/2019
Type of Reportable Event	Death
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 revealed no manufacturing nonconformities that would have contributed to this event.The reported patient effects of angina and death, are listed in the xience sierra, ce eluting coronary stent systems (eccs) 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, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that on (b)(6) 2019, the patient presented with a non-st-elevation myocardial infarction (nstemi).The procedure was to treat the mid left anterior descending artery.A 2.75 x 23mm xience sierra stent was implanted on (b)(6) 2019.It was confirmed that the patient was compliant with dual antiplatelet drug therapy.On (b)(6) 2019, the patient was readmitted due to enzyme elevation and chest pain.Percutaneous coronary intervention was attempted but the patient was uncooperative and therefore procedure was aborted.Then the patient developed respiratory failure and was admitted to home hospice.On (b)(6) 2019, the patient died at home.An autopsy was not performed.The cause of death is unknown.Per the physician the device did not cause or contribute to the patient death.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: 8666587
• Report Number: 2024168-2019-04350
• Device Sequence Number: 19324906
• Product Code: NIQ
• UDI-Device Identifier: 08717648227196
• UDI-Public: 08717648227196
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/04/2019

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: 11/04/2019
• Device Catalogue Number: 1550275-23
• Device Lot Number: 8103041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 06/04/2019
• 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: Death
• Patient Age: 89 YR
• Patient Weight: 31