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

Model Number	1550275-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Stenosis (2263)
Date of Event	08/21/2020
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.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) 2020, the patient presented with elevated cardiac enzymes and a proximal circumflex (cx), 99% stenosed lesion and 1st obtuse marginal (om), 80% stenosed lesion.Pre-dilatation was performed on the proximal cx, and a 2.5x12mm xience sierra stent and a 2.75x15mm stent were implanted.A 2.25x8mm and a 2.5x12mm xience sierra stent were implanted in the 1st om.Post-dilatation had been performed with timi flow iii and 0% residual stenosis.There was no device malfunction reported.On (b)(6) 2020, the patient presented with chest pain.An elective cardio-angiogram was performed displaying proximal cx 70% restenosis, 1st om, 90% restenosis, right coronary artery 50% restenosis.Reportedly, only the proximal cx 2.75x15mm xience sierra stent restenosed.The 2.5x12mm, 2.25x8mm, and 2.5x12mm xience sierra stents had remained patent, without restenosis.As treatment, another percutaneous coronary intervention was performed in the 1st om and a stent was implanted in the proximal cx.The event resolved without sequela.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: 10564061
• Report Number: 2024168-2020-07884
• Device Sequence Number: 11072953
• Product Code: NIQ
• UDI-Device Identifier: 08717648227172
• UDI-Public: 08717648227172
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2020

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: 09/12/2020
• Device Model Number: 1550275-15
• Device Catalogue Number: 1550275-15
• Device Lot Number: 9090641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 09/21/2020
• 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: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 91