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

Catalog Number	1074300-28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	09/13/2019
Type of Reportable Event	Death
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 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 the procedure was performed to treat a lesion in an unknown artery.It was noted that the patient had a previous open-heart surgery, several heart attacks, and other non-abbott stents implanted.On (b)(6) 2017, one 4.0x15 mm xience xpedition stent and one 3.0x28 mm xience xpedition stent were successfully implanted.On (b)(6) 2018, one 3.5x33mm xience xpedtion stent was successfully implanted.On (b)(6) 2019, the patient went into cardiac arrest and died at home.An autopsy was not performed.The relationship between the stents and the patient death is unknown.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.The reported patient effect of death is listed in the xience xpedition, everolimus eluting coronary stent system (eecss), instructions for use, as a known patient effect of coronary stenting procedures.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the information reviewed, there is no indication of a product quality issue.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 of the device.Correction - part and lot number, expiration date and udi.Correction - manufacturing date.

• Brand Name: XIENCE XPEDITION
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9297854
• Report Number: 2024168-2019-13380
• Device Sequence Number: 11390352
• Product Code: NIQ
• UDI-Device Identifier: 08717648162633
• UDI-Public: 08717648162633
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2019

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: 03/13/2019
• Device Catalogue Number: 1074300-28
• Device Lot Number: 6030941
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 12/13/2019
• 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: 3.0 X 28 MM XIENCE XPEDITION STENT; 3.5 X 33 MM XIENCE XPEDITION STENT; 3.0 X 28 MM XIENCE XPEDITION STENT; 3.5 X 33 MM XIENCE XPEDITION STENT
• Outcome Attributed to Adverse Event: Death
• Patient Age: 87 YR