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

Catalog Number	1125275-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Death (1802); Cardiac Enzyme Elevation (1838); Stenosis (2263)
Date of Event	08/13/2018
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 identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of angina and stenosis are listed in the xience alpine, everolimus eluting coronary stent system (eecss), 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 manufacture, design or labeling of the device.
Event or Problem Description
It was reported that on 03/07/2018, the patient underwent a coronary stenting procedure with implantation of a 2.75 x 23 mm xience alpine stent in the mid right coronary artery (rca).On (b)(6) 2018, the patient began to experience chest discomfort.The patient was re-hospitalized on (b)(6) 2018.Cardiac enzymes were elevated; however, electrocardiogram noted no changes suggestive of myocardial infarction.Coronary catheterization was performed and noted in-stent restenosis.Coronary intervention was performed and the event resolved on (b)(6) 2018.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).The reported patient effect of death is listed in the xience alpine, everolimus eluting coronary stent system (eecss), instructions for use (ifu) as known patient effects of coronary stenting procedures.A conclusive cause for the reported death 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 of the device.
Additional Manufacturer Narrative
(b)(4).Correction: type of reportable event.
Event or Problem Description
Subsequent to the initial 30-day medwatch report, the following information was received: on (b)(6) 2018, the patient died at home.No intervention was performed.No additional information was provided.

• Brand Name: XIENCE ALPINE 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: 7940673
• Report Number: 2024168-2018-07724
• Device Sequence Number: 11247013
• Product Code: NIQ
• UDI-Device Identifier: 08717648199271
• UDI-Public: 08717648199271
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/22/2019

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: 10/05/2020
• Device Catalogue Number: 1125275-23
• Device Lot Number: 7092641
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2018
• Supplement Date Received by Manufacturer: 02/14/2019; 03/19/2019
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 03/11/2019; 03/22/2019
• 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; Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 63