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

Model Number	1550300-18
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	11/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
Patient id: (b)(6).It was reported that on (b)(6) 2020 a 3.0 x 18 mm xience sierra stent was implanted in the mid left anterior descending (lad) coronary artery.On (b)(6) 2020, the patient underwent a right and left heart catheterization and was found to have restenosis in the proximal lad, identified as the target lesion.An additional stent was implanted.There was no additional information provided.
Event or Problem Description
Subsequent to the initial mdr, additional information was received.Per study physician, the new area of stenosis was not in the 3.0 x 18 mm xience sierra stent implanted in the mid left anterior descending artery.The adverse event of stenosis requiring intervention was not related to the implanted stent or the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.Subsequent information revealed that there was no complaint against this device.No investigation required.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.B1, b2, h1: a serious injury requiring hospitalization and intervention did not occur.H6: health effect - clinical code 2263 removed.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11190102
• Report Number: 2024168-2021-00556
• Device Sequence Number: 17082759
• Product Code: NIQ
• UDI-Device Identifier: 08717648227264
• UDI-Public: 08717648227264
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2021

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: 05/06/2020
• Device Model Number: 1550300-18
• Device Catalogue Number: 1550300-18
• Device Lot Number: 9042942
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 01/18/2021
• Supplement Report FDA Received Date: 01/28/2021
• 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: 52 YR
• Patient Weight: 105