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

Catalog Number	1125300-12
Health Effect - Clinical Codes	Angina (1710); Dyspnea (1816); Myocardial Infarction (1969); Nausea (1970); Thrombosis (2100); Diaphoresis (2452)
Date of Event	05/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.It should be noted that the reported patient effects of angina, dyspnea, myocardial infarction, nausea and thrombosis are listed in instructions for use (ifu) xience alpine everolimus eluting coronary stent systems as a known patient effect(s) 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.
Event or Problem Description
(b)(6) study report.It was reported that on (b)(6) 2018, a 3.0x12mm xience alpine stent was successfully implanted at the mid left anterior descending (lad) coronary artery, 90% stenosed lesion.Starting on (b)(6) 2018, the patient was hospitalized for initial abdominal pain, dyspnea, nausea/vomiting, and diaphoresis.An st elevated myocardial infarction (stemi) was diagnosed, elevated cardiac enzymes were noted, and mid lad thrombus were observed.As treatment, balloon angioplasty and a thrombectomy were performed at the mid lad.Medications were also provided.On (b)(6) 2018, the event resolved without sequela and the patient was discharged from the hospital.No additional information was provided regarding this issue.

• 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: 7598057
• Report Number: 2024168-2018-04448
• Device Sequence Number: 10807296
• Product Code: NIQ
• UDI-Device Identifier: 08717648199332
• UDI-Public: 08717648199332
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/13/2018

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 Expiration Date: 10/06/2019
• Device Catalogue Number: 1125300-12
• Device Lot Number: 6092941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 06/13/2018
• 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; Disability
• Patient Age: 52 YR
• Patient Weight: 127