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

Model Number	1550300-15
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); Test Result (2695)
Date of Event	12/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Patient id: (b)(6).It was reported that on (b)(6) 2019, a percutaneous coronary intervention was performed on the right coronary artery (rca), 95% stenosed lesion.A 3.0x15mm xience sierra stent (1550300-15, 9011441) was implanted in the distal rca without complication.Following, a 3.0x18 and a 3.5x18mm xience sierra stent were implanted in the mid rca without complication.Acceptable results were noted as the rca was observed with timi flow iii and 0% diameter stenosis following stent implantation.On (b)(6) 2019, the patient experienced worsening jaw pain and a positive non-stress test was noted.The patient was admitted to the hospital with coronary artery disease.Another cardiac catheritization was performed and target vessel disease was observed.80% proximal lad stenosis, 99% distal lcx stenosis, 99% proximal rca stenosis, widely patent stent (stent not specified), and 70% distal rca stenosis.On (b)(6) 2020, a coronary artery bypass graft (cabg) was performed in the lad, om and pda.Elevated troponin was noted following.The event resolved without sequela.No additional information was provided regarding this issue.
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 angina and stenosis are listed in the xience sierra, everolimus eluting coronary stent system instructions for use, as known patient effects 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 reported treatments appear 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 of the device.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10261450
• Report Number: 2024168-2020-05693
• Device Sequence Number: 11627648
• Product Code: NIQ
• UDI-Device Identifier: 08717648227257
• UDI-Public: 08717648227257
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 08/21/2020

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: 01/20/2020
• Device Model Number: 1550300-15
• Device Catalogue Number: 1550300-15
• Device Lot Number: 9011441
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 08/21/2020
• 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: 2 XIENCE SIERRA STENTS
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 64 YR
• Patient Weight: 57