MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE DRUG ELUTING CORONARY STENT; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number	1550250-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Non specific EKG/ECG Changes (1817); Embolism (1829); Cardiac Enzyme Elevation (1838)
Date of Event	11/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2019001.The device was not returned for evaluation.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 embolism are listed in the xience sierra everolimus eluting coronary stent systems 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.
Event or Problem Description
Patient id (b)(6).It was reported that the procedure was performed to treat a lesion in the distal right coronary artery (rca).A 2.5 x 16 mm xience sierra stent was implanted.Post stenting, the patient had complaints of chest paint.Electrocardiogram (ecg) revealed st elevation and repeat angiography revealed 100% total occlusion in the mid portion of the first marginal branch.There was no obvious lesion noted in this location prior to stent placement in the distal rca and there was suspicion for spontaneous dissection; however, atheroemboli could not be excluded.Revascularization was performed in the 1st obtuse marginal, with implantation of an additional stent.No additional information was provided.

• Brand Name: XIENCE DRUG ELUTING CORONARY STENT
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9492998
• Report Number: 2024168-2019-14734
• Device Sequence Number: 1304955
• Product Code: NIQ
• UDI-Device Identifier: 08717648227097
• UDI-Public: 08717648227097
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P070015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/18/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/17/2020
• Device Catalogue Number: 1550250-15
• Device Lot Number: 9041141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 12/19/2019
• 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: 55