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

Model Number	1550275-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Cardiac Enzyme Elevation (1838); Stenosis (2263)
Date of Event	01/24/2020
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 effects of stenosis and dyspnea are listed in the xience sierra, everolimus eluting coronary stent system instructions for use as known patient effects of coronary stenting procedures.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
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 proximal left anterior descending (lad) coronary artery lesion and a 2.75x23mm xience sierra stent (1550275-23, 8103041) was successfully implanted in the mid lad.Reportedly, there were no procedural complications.Starting on (b)(6) 2020, the patient started experiencing dyspnea.On (b)(6) 2020, the patient was hospitalized.Imaging was performed and 80% stenosis was observed in the mid lad, 2.75x23mm xience sierra stent.The proximal 3.0x28mm xience sierra stent remained patent.Elevated cardiac enzymes were noted; however, the patient had not had a myocardial infarction.Balloon angioplasty was performed and medications were provided.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: 9757385
• Report Number: 2024168-2020-01782
• Device Sequence Number: 16610802
• Product Code: NIQ
• UDI-Device Identifier: 08717648227196
• UDI-Public: 08717648227196
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 02/26/2020

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: 11/04/2019
• Device Model Number: 1550275-23
• Device Catalogue Number: 1550275-23
• Device Lot Number: 8103041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 02/26/2020
• 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: 83 YR
• Patient Weight: 65