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

Catalog Number	1074300-15
Health Effect - Clinical Codes	Non specific EKG/ECG Changes (1817); Embolism (1829)
Date of Event	06/03/2017
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 identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents.The reported patient effect of an embolism is listed in the xience xpedition, everolimus eluting coronary stent system instructions for use as a known patient effect of coronary stenting procedures.The investigation determined the reported failure to advance appears to be related to the operational context of the procedure.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 the design, manufacture or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a moderately tortuous, eccentric and mildly calcified de novo mid right coronary artery that was 99% stenosed.The patient presented with severe coronary artery disease in 3 vessels, an inferior segment elevated myocardial infarction (stemi), and thrombus with a timi i flow.During the advancement of a 3.0 x 15 mm xience xpedition stent, embolization of thrombus occurred with st elevation.Therefore, the stent failed to cross the lesion and it was removed and replaced with a 3.0 x 23 xience xpedition stent to successfully complete the procedure.There was no adverse patient sequela reported.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: 6779012
• Report Number: 2024168-2017-06544
• Device Sequence Number: 1116119
• Product Code: NIQ
• UDI-Device Identifier: 08717648162336
• UDI-Public: 08717648162336
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/09/2017

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: 02/02/2020
• Device Catalogue Number: 1074300-15
• Device Lot Number: 7012541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2017
• Initial Report FDA Received Date: 08/09/2017
• 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: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 100