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

Model Number	1550275-38
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Stenosis (2263)
Date of Event	02/20/2020
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 effect(s) of angina and stenosis are listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary procedures.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.However, the treatment appears 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.The 2.75x33mm xience sierra stent mentioned has been previously reported in medwatch report reference 2024168-2019-10420-00 and 2024168-2019-10420-001, echo event, (b)(4).
Event or Problem Description
Patient id: (b)(6).It was reported that on (b)(6) 2018, the patient presented with a mid-left anterior descending (lad) coronary artery, 70% stenosed lesion.A 2.75x33mm xience sierra stent was implanted with acceptable results and without complication.On (b)(6) 2019, a xience sierra stent 2.75x38mm was implanted to treat restenosis in the previously implanted, mid lad 2.75x33mm xience sierra stent (previously reported under another manufacturer mfr#).On (b)(6) 2020, the patient was hospitalized for chest pain.Per imaging, the mid lad had 95% occlusion with restenosis.Additional angioplasty was performed as treatment, placing a non-abbott stent in the mid lad.There was no device malfunction and 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: 10928622
• Report Number: 2024168-2020-10035
• Device Sequence Number: 16954420
• Product Code: NIQ
• UDI-Device Identifier: 08717648227226
• UDI-Public: 08717648227226
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• 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): 12/01/2020

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: 04/15/2020
• Device Model Number: 1550275-38
• Device Catalogue Number: 1550275-38
• Device Lot Number: 9040941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 12/01/2020
• 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: 81 YR
• Patient Weight: 67