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

Model Number	1550300-28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Cardiac Enzyme Elevation (1838); Stenosis (2263)
Date of Event	01/02/2020
Type of Reportable Event	Serious Injury
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.It should be noted that the reported patient effect(s) of stenosis and angina are listed in the xience sierra everolimus eluting coronary stent systems instructions for use 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.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.
Event or Problem Description
Patient id: (b)(6).It was reported that on (b)(6) 2019, a percutaneous coronary intervention (pci) was performed.A 3.0x28mm xience sierra stent was successfully implanted in the mid left anterior descending (lad) coronary artery lesion.There were no procedure complications.On (b)(6) 2020, the patient was hospitalized for unstable chest pain.Elevated cardiac enzymes were observed and an electrocardiogram was performed without any new myocardial infarction (mi).On (b)(6) 2020, another pci was performed in the mid lad restenosed, 3.0x28mm xience sierra stent.On (b)(6) 2020, revascularization was done on a non-target vessel.A dissection was observed, treated with another stent.Reportedly, the dissection was not located at the 3.0x28mm xience sierra site, was unrelated to the 3.0x28mm xience sierra stent, and unrelated to the index procedure.Reportedly, there was no device malfunction regarding the mid lad, 3.0x28mm xience sierra stent.The event resolved without sequela.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: 9649493
• Report Number: 2024168-2020-01058
• Device Sequence Number: 2800690
• Product Code: NIQ
• UDI-Device Identifier: 08717648227288
• UDI-Public: 08717648227288
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/30/2020

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: 03/18/2020
• Device Model Number: 1550300-28
• Device Catalogue Number: 1550300-28
• Device Lot Number: 9030841
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 01/30/2020
• 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: 48 YR
• Patient Weight: 88