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

Catalog Number	1074350-28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Stenosis (2263)
Date of Event	08/29/2018
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.There was no reported device malfunction.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 stenosis are listed in the xience xpedition, everolimus eluting coronary stent system 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.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) 2013, the patient underwent a coronary procedure to treat the target lesion in the proximal right coronary artery (rca).A xience xpedition stent was implanted.On (b)(6) 2018, the patient was seen with complaints of chest pain.As the patient had been non-compliant with aspirin administration since (b)(6) 2018, the aspirin was discontinued.Coronary angiography was performed on (b)(6) 2018 and noted 50% re-stenosis in the target lesion and 90% stenosis in the mid rca.Medication was administered on (b)(6) 2018 and the angina resolved on (b)(6) 2018.Coronary angiography was performed on (b)(6) 2018 and noted that the stenosis was within 5 mm of the implanted stent.Revascularization with additional stent implantation was performed and the event resolved on (b)(6) 2018.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: 7916502
• Report Number: 2024168-2018-07486
• Device Sequence Number: 770354
• Product Code: NIQ
• UDI-Device Identifier: 08717648162565
• UDI-Public: 08717648162565
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/27/2018

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: 06/18/2015
• Device Catalogue Number: 1074350-28
• Device Lot Number: 3060741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2018
• Initial Report FDA Received Date: 09/27/2018
• 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: 62 YR
• Patient Weight: 76