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

Catalog Number	1074250-15
Health Effect - Clinical Codes	Angina (1710); Thrombosis (2100)
Date of Event	11/28/2016
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.Angina and thrombosis are listed in the xience xpedition everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure on (b)(6) 2014 was to treat a mildly tortuous and mildly calcified lesion in the first diagonal artery.The patient presented with acute myocardial infarction (ami) a 2.5x15mm xience xpedition stent was implanted.On (b)(6) 2016 the patient was re-admitted and presented with chest pain.Thrombosis was confirmed with an intravascular ultrasound in the stented segment.Thrombus aspiration was performed and an unknown stent was deployed, which reconstructed the blood flow.The physician made a comment stating, "it is assumed there is no issue with the stent itself.The patient has been taking plavix.However, there are a certain number of patients on whom plavix does not take effect.It seems plavix is not effective on this patient.Plavix was replaced with effient." the outcome was successful and the patient is in good condition.No additional information was provided.

• Brand Name: XIENCE XPEDITION 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: 6183505
• Report Number: 2024168-2016-08997
• Device Sequence Number: 970094
• Product Code: NIQ
• UDI-Device Identifier: 08717648162138
• UDI-Public: (01)08717648162138
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/16/2016

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 Catalogue Number: 1074250-15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2016
• Initial Report FDA Received Date: 12/16/2016
• 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
• Patient Age: 70 YR
• Patient Weight: 81