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	11/13/2019
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 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 stenosis, death, angina, and myocardial infarction listed in the xience sierra, everolimus eluting coronary stent systems instructions for use as 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.However, the treatment appears 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.The 2.75 x 15 mm xience sierra stent referenced is being filed under a separate medwatch report #.Na.
Event or Problem Description
Patient id: (b)(6).It was reported that on (b)(6) 2019 the xience sierra 3.25x23 mm stent was implanted in the proximal left anterior descending (lad) coronary artery and the xience sierra 2.75x15 mm was implanted in the proximal circumflex (cx) coronary artery.On (b)(6) 2019 the patient had right sided pain radiating to the neck and jaw.The cardiac enzymes indicated that the patient had a myocardial infarction medication was administered on (b)(6)2019.Diagnostic imaging only was performed on (b)(6) 2019.The angiogram found 90 to 99% restenosis in the lad and lcx stents.There was also restenosis in the obtuse marginal and the right coronary arteries.The patient went into cardiac arrest on (b)(6) 2019, but was successfully resuscitated.Subsequently, the patient status was changed to do not resuscitate.Cardiac arrest occurred again and the patient expired on (b)(6) 2019.No additional information was provided.

• 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: 9566876
• Report Number: 2024168-2020-00487
• Device Sequence Number: 2866290
• Product Code: NIQ
• UDI-Device Identifier: 08717648227356
• UDI-Public: 08717648227356
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/08/2020

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: 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: 12/16/2019
• Initial Report FDA Received Date: 01/08/2020
• 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 SIERRA 2.75 X 15 MM STENT
• Outcome Attributed to Adverse Event: Death
• Patient Age: 60 YR
• Patient Weight: 92