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

Catalog Number	1550225-18
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Enzyme Elevation (1838); Occlusion (1984)
Date of Event	10/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2019001.The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that a 2.25x18mm xience sierra was implanted in the circumflex coronary artery on (b)(6) 2019.On (b)(6) 2019, the patient was re-admitted with elevated troponin enzymes.Imaging found that there was no flow down the circumflex artery.The circumflex artery was occluded in the mid portion where the stent had been implanted.A balloon was advanced to reestablish flow.No additional treatment was performed as the collateral circulation was sufficient.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.
Additional Manufacturer Narrative
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.The reported patient effect of occlusion is listed in the xience sierra, everolimus eluting coronary stent system, instructions for use, as a known patient effect of coronary stenting procedures.A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined; however, the subsequent treatments appear to be related to the circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

• 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: 9317192
• Report Number: 2024168-2019-13519
• Device Sequence Number: 10914205
• Product Code: NIQ
• UDI-Device Identifier: 08717648227028
• UDI-Public: 08717648227028
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1550225-18
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/21/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 12/05/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 61 YR