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

Model Number	1074275-18
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Intracranial Hemorrhage (1891); Myocardial Infarction (1969); Neurological Deficit/Dysfunction (1982)
Date of Event	03/09/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device 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
Patient id: (b)(6).It was reported that on (b)(6) 2020, the patient presented with a recent non-st elevated myocardial infarction (nstemi).No pre-dilatation was performed.A 2.75x33mm and 2.75x18mm xience stent were implanted in the left anterior descending (lad), coronary artery lesion.A 2.75x18 and a 2.75x8mm xience stent were implanted in the diagonal coronary artery, 80% stenosed lesion.Reportedly, stent placements angiographic appearance was acceptable and post-dilatation was performed.The end result was timi flow 3 and 0% diameter stenosis.Post-procedure, the patient's troponin increased and a new myocardial infarction (mi) was diagnosed.The patient had an intracranial bleed with herniation worsened by medical therapy for mi and had become unresponsive.On (b)(6) 2020, the patient expired.Per physician, the event was unrelated to the device and unrelated to the procedure.There was no device malfunction.No additional information was provided regarding this issue.
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.The reported patient effect(s) of myocardial infarction and death are listed in the xience xpedition everolimus eluting coronary stent systems instructions for as a known patient effect(s) of coronary stenting procedures.A conclusive cause for the reported patient effect(s), 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.

• Brand Name: XIENCE XPEDITION 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: 9917838
• Report Number: 2024168-2020-03293
• Device Sequence Number: 752376
• Product Code: NIQ
• UDI-Device Identifier: 08717648162244
• UDI-Public: 08717648162244
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2020

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: 03/19/2022
• Device Model Number: 1074275-18
• Device Catalogue Number: 1074275-18
• Device Lot Number: 9031341
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 04/08/2020
• 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 STENTS (X3).; XIENCE STENTS (X3)
• Outcome Attributed to Adverse Event: Death
• Patient Age: 59 YR
• Patient Weight: 64