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

Catalog Number	1125300-18
Health Effect - Clinical Codes	Angina (1710); Non specific EKG/ECG Changes (1817); Thrombosis (2100)
Date of Event	05/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).There was no reported device malfunction and the product was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of angina and thrombosis are listed in the xience alpine, everolimus eluting coronary stent system (eecss), instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined and there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.The graftmaster stent is filed under a separate medwatch report.
Event or Problem Description
It was reported that the graftmaster stent was used to treat a coronary aneurysm that occurred in the proximal right coronary artery (rca).The graftmaster was deployed covering the entire length of the aneurysm.A 3.0 x 18 mm xience alpine was placed at the proximal segment of the graftmaster.Angiography with an ivus catheter showed timi 3 flow.Prior to leaving the catheterization lab the patient complained of severe chest pain and the echocardiogram (ecg/ekg) revealed new st elevation of the inferior leads and evidence of stent thrombosis in the entire stented region.Balloon angioplasty was performed, resolving the thrombus and improving the blood flow in the vessel.Angiography and intravascular ultrasound (ivus) revealed great apposition of the stents.There was no reported adverse patient sequela.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: 6644901
• Report Number: 2024168-2017-05105
• Device Sequence Number: 981387
• Product Code: NIQ
• UDI-Device Identifier: 08717648199356
• UDI-Public: (01)08717648199356(17)200227(10)7021461
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/15/2017

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: 02/27/2020
• Device Catalogue Number: 1125300-18
• Device Lot Number: 7021461
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2017
• Initial Report FDA Received Date: 06/15/2017
• 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: 54 YR
• Patient Weight: 90