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

Model Number	1550250-28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Fatigue (1849); Stenosis (2263)
Date of Event	09/30/2020
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.The reported patient effect of stenosis is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.However, the 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.
Event or Problem Description
Patient id: (b)(6): it was reported that on (b)(6) 2019, the procedure was performed to treat a lesion in the 1st obtuse marginal artery.The 2.5 x 28 mm xience sierra stent was implanted at 12 atmospheres.Approximately 20 months post stenting procedure, on (b)(6) 2020, the patient experienced shortness of breath and fatigue.The patient was admitted for a coronary procedure and in-stent restenosis was noted in the obtuse marginal artery.A sculpting balloon was used.The event resolved without sequela and the patient was discharged home the same day.No additional information was provided.

• 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: 10702308
• Report Number: 2024168-2020-08716
• Device Sequence Number: 17014761
• Product Code: NIQ
• UDI-Device Identifier: 08717648227127
• UDI-Public: 08717648227127
• 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
• Report Date (Section B): 10/19/2020

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: 09/23/2019
• Device Model Number: 1550250-28
• Device Catalogue Number: 1550250-28
• Device Lot Number: 8091441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 10/19/2020
• 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: 64 YR
• Patient Weight: 101