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

Model Number	1550225-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	12/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.It should be noted that the reported patient effect of stenosis is listed in the xience sierra, everolimus eluting coronary stent system instructions for use as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.Based on the information reviewed, 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 on (b)(6) 2019, a 2.25x23mm xience sierra stent (1550225-23, 8091341) was successfully implanted in the mid left anterior descending (lad) coronary artery.There were no procedure complications.On (b)(6) 2019, the patient presented with dyspnea and for diagnostic imaging.Imaging displayed 90% stenosis in a mid- lad vein graft and the 2.25x23mm xience sierra stent had 5% stenosis.The patient was sent for another percutaneous coronary intervention and another stent was implanted in the mid lad vein graft and within 5mm of the 2.25x23mm xience sierra stent.The event resolved.Per physician, the event was unrelated to the xience sierra stent and unrelated to the index procedure.Per physician, the dyspnea was related to the patients aortic stenosis and unrelated to the coronary artery disease.There was no device malfunction.No additional information was provided regarding this issue.

• 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: 9678595
• Report Number: 2024168-2020-01266
• Device Sequence Number: 11616693
• Product Code: NIQ
• UDI-Device Identifier: 08717648227035
• UDI-Public: 08717648227035
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/06/2020

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: 09/19/2019
• Device Model Number: 1550225-23
• Device Catalogue Number: 1550225-23
• Device Lot Number: 8091341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 02/06/2020
• 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: 69 YR
• Patient Weight: 101