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

Catalog Number	1550325-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Myocardial Infarction (1969); Stenosis (2263)
Date of Event	10/17/2019
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 angina, stenosis and myocardial infarction are listed in the xience sierra, everolimus eluting coronary stent system instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; however, the subsequent treatments appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.The additional xience sierra stent mentioned is filed under a separate medwatch report number.
Event or Problem Description
Patient id: (b)(6).It was reported that on (b)(6) 2018, a percutaneous coronary intervention (pci) was performed, treating the right coronary artery (rca) lesion.A 3.25x23mm and a 3.5x38mm xience sierra stent were implanted with standard post-dilatation.Reportedly, there was no issue with implantation nor stent expansion.Procedural results showed timi flow 3 and 0% diameter stenosis.On (b)(6) 2019, the patient was admitted to the hospital for unstable chest pain.A repeat cardiac catheterization was performed.The mid left anterior descending (lad) had stenosis and the rca was observed with mild to moderate in-stent restenosis (isr) in both stents.On (b)(6) 2019, the patient was admitted to the hospital again for unstable angina.Elevated cardiac enzymes were noted and a myocardial infarction was diagnosed.A repeat coronary angiogram was performed with no change noted from the previous angiogram.The patient is scheduled for an outpatient target lesion revascularization.Medication was provided.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: 9329381
• Report Number: 2024168-2019-13619
• Device Sequence Number: 2615898
• Product Code: NIQ
• UDI-Device Identifier: 08717648227356
• UDI-Public: 08717648227356
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/15/2019

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: 09/19/2019
• Device Catalogue Number: 1550325-23
• Device Lot Number: 8091341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: XIENCE SIERRA STENT; XIENCE SIERRA STENT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 66 YR
• Patient Weight: 73