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

Catalog Number	1550400-38
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Occlusion (1984); Weakness (2145)
Date of Event	10/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.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 occlusion and cerebrovascular accident are listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use (eifu) 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
Patient id: (b)(6).It was reported that the procedure was performed to treat a lesion in the distal right coronary artery (rca).A 4.0 x 38 mm xience sierra stent was implanted.During stent deployment, a marginal side branch was blocked.Additional balloon angioplasty was performed to open the vessel.Several hours post stenting procedure, left sided weakness and facial droop were noted.Computed tomography, angiography and magnetic resonance imaging were performed.A small embolic stroke was diagnosed in the right hemisphere.The patient was kept overnight for observation.No treatment was provided.

• Brand Name: XIENCE SIERRA
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9262288
• Report Number: 2024168-2019-13092
• Device Sequence Number: 19747843
• Product Code: NIQ
• UDI-Device Identifier: 08717648227547
• UDI-Public: 08717648227547
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• 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): 10/31/2019

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: 06/17/2020
• Device Catalogue Number: 1550400-38
• Device Lot Number: 9061142
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 10/31/2019
• 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; Disability
• Patient Age: 69 YR
• Patient Weight: 114