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

Catalog Number	1125350-18
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Angina (1710); Myocardial Infarction (1969); Stenosis (2263); Diaphoresis (2452)
Date of Event	10/27/2018
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 analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.It should be noted that the reported patient effects of angina, stenosis, and myocardial infarction are listed in the xience alpine, everolimus eluting coronary stent system, instructions for use as known patient effects of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported difficulty to deploy (wall apposition); however, the subsequent treatments appear to be related to the circumstances of the procedure.A conclusive cause for the reported patient effect(s), 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) 2018, a 3.5x18m xience alpine stent was successfully implanted in the mid right coronary artery lesion (rca).On (b)(6) 2018, the patient was hospitalized with chest pain and diaphoresis.Elevated troponin was noted and a non-st elevated myocardial infarction was diagnosed.Per imaging, stent restenosis with recoil were observed.As treatment, angioplasty was performed.The event resolved without sequela.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: 8345360
• Report Number: 2024168-2019-01160
• Device Sequence Number: 2307117
• Product Code: NIQ
• UDI-Device Identifier: 08717648199530
• UDI-Public: 08717648199530
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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
• Report Date (Section B): 02/15/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/19/2020
• Device Catalogue Number: 1125350-18
• Device Lot Number: 7091241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 02/15/2019
• 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: ASPIRIN, CLOPIDOGREL
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 59 YR
• Patient Weight: 127