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

Model Number	1550250-38
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Stenosis (2263); Test Result (2695)
Date of Event	06/26/2020
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 angina and stenosis are listed in the xience sierra everolimus eluting coronary stent systems instructions for use as known patient effects of coronary procedures.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.The additional xience sierra device referenced filed under separate medwatch report number.
Event or Problem Description
Patient id: (b)(6).It was reported that on (b)(6) 2019, the patient presented with a recent non-st elevated myocardial infarction and a 70% stenosed lesion within the mid right coronary artery (rca).Pre-dilatation was performed within the mid rca and a 2.5x38mm (1550250-38, 9020841) and a 2.75x23mm (1550275-23, 8091141) xience sierra stent were implanted.Post-dilatation was performed.0% residual stenosis was noted without a device issue reported.On (b)(6) 2020, during a follow-up, the patient reported experiencing ongoing, intermittent chest pain that was relieved with rest.As treatment, the patient's medication (nitroglycerine) was provided/adjusted.On (b)(6) 2020, during a follow-up, the patient presented with worsening chest pain.Per nuclear stress test, st segment depression was observed.On (b)(6) 2020, the patient continued to have chest pain.The patient was hospitalized and in-stent restenosis was observed in both rca, xience sierra stents.As treatment, angioplasty was performed on the 99% occluded lesion within the rca.The event resolved.No additional information was provided regarding this issue.

• 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: 10454673
• Report Number: 2024168-2020-07117
• Device Sequence Number: 17045267
• Product Code: NIQ
• UDI-Device Identifier: 08717648227141
• UDI-Public: 08717648227141
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• 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): 08/26/2020

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: 02/17/2020
• Device Model Number: 1550250-38
• Device Catalogue Number: 1550250-38
• Device Lot Number: 9020841
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 08/26/2020
• 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 STENT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 47