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

Model Number	1550350-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Thrombosis (2100); Stenosis (2263)
Date of Event	01/29/2020
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.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; however, the reported treatments appear to be related to the operational context of the procedure.The reported patient effects of dyspnea, myocardial infarction, hypotension, thrombosis and stenosis are listed in the xience sierra, everolimus eluting coronary stent system ifu 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 transluminal coronary intervention (ptci) was performed on the proximal right coronary artery (rca), 95% stenosed lesion.A 3.25x28mm xience sierra stent was successfully implanted in the proximal rca.On (b)(6) 2020, the patient presented with myocardial infarction, severe in-stent restenosis and in-stent thrombosis.Medications were administered.On (b)(6) 2020 aspiration thrombectomy and revascularization was performed and a xience sierra 3.5x23mm stent was implanted within the xience sierra 3.25x28 stent.The adverse patient event resolved on (b)(6) 2020.(that event was previously reported on another medwatch report number.) on (b)(6) 2020, the patient was admitted to the hospital with fatigue, hypotension, dyspnea and elevated troponin.Myocardial infarction was diagnosed.A heparin drip was initiated.Per imaging, in-stent stenosis was observed in the rca and the left anterior descending (lad) coronary artery had a complete total occlusion.On (b)(6) 2020, another ptci with thrombectomy/thrombolysis was performed in the proximal rca.A non-abbott stent was placed as treatment within the xience sierra stent.Medications were provided and an intra-aorta balloon pump (iabp) was placed.On (b)(6) 2020, another ptci was performed in the mid rca.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: 9789111
• Report Number: 2024168-2020-02022
• Device Sequence Number: 1866610
• Product Code: NIQ
• UDI-Device Identifier: 08717648227431
• UDI-Public: 08717648227431
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2020

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: 08/14/2020
• Device Model Number: 1550350-23
• Device Catalogue Number: 1550350-23
• Device Lot Number: 9080941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 03/04/2020
• 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; Disability
• Patient Age: 73 YR
• Patient Weight: 81