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

Catalog Number	1125300-18
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Angina (1710); Myocardial Infarction (1969)
Date of Event	09/10/2018
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 evaluation.The reported patient effects of angina and myocardial infarction are listed in the xience alpine, everolimus eluting coronary stent system (eecss), instructions for use, as known patient effects 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.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 (b)(6) 2018 one 2.25x15 mm xience alpine stent was implanted in the proximal left anterior descending coronary artery and one 3.0x18 mm xience alpine stent was implanted in the distal left circumflex coronary artery.The patient was compliant with the dual antiplatelet therapy, but clopidogrel was discontinued by the physician at the 3 month assessment.On (b)(6) 2018 the patient had angina that lasted a day and a half.This was diagnosed as a non st elevation myocardial infarction.Long acting nitrates were administered and brilinta was prescribed.The condition resolved on (b)(6) 2018.No additional information was provided.
Additional Manufacturer Narrative
Device codes: 3190 not labeled internal file number - (b)(4).The additional xience alpine referenced in b5 is being filed under a separate medwatch report #.
Event or Problem Description
Subsequent to the previously filed report, additional information was received that the physician suspected that the myocardial infarction may be related to an unknown device deficiency of the xience alpine stents.A coronary angiogram was not 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: 8102627
• Report Number: 2024168-2018-09032
• Device Sequence Number: 1620473
• Product Code: NIQ
• UDI-Device Identifier: 08717648199356
• UDI-Public: 08717648199356
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2019

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: 11/20/2020
• Device Catalogue Number: 1125300-18
• Device Lot Number: 7110661
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 11/26/2018
• Supplement Report FDA Received Date: 06/11/2019
• 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: 2.25X15 MM XIENCE ALPINE, ASPIRIN, TICAGRELOR; 2.25X15 MM XIENCE ALPINE, ASPIRIN, TICAGRELOR
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 88 YR
• Patient Weight: 88