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

Model Number	1550400-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia (1942); Stenosis (2263); Test Result (2695)
Date of Event	08/05/2020
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 (b)(6).It was reported that on (b)(6) 2019, the patient presented with angina and a severely calcified, 70% stenosed lesion within the proximal left anterior descending (lad) coronary artery.Pre-dilatation and an atherectomy were performed.Following, a 4.0x15mm xience sierra stent (1550400-15, 8101641) was implanted without a device issue reported.The diameter stenosis was reduced to 0% with timi flow iii.On (b)(6) 2020, the patient was hospitalized for known in-stent restenosis which was being medically managed.A recent stress test revealed a small zone of reversibility in the inferior apex, suggesting mild ischemia.No additional information was provided regarding this issue.
Additional Manufacturer Narrative
Subsequent information revealed that there was no complaint against this xience sierra device.Based on the information reviewed, there remains no indication of a product quality issue with respect to manufacture, design or labeling.H6: result codes 213 and 114 removed.H6: conclusion codes 22 and 4311 removed.
Event or Problem Description
Subsequent to the previous medwatch report, the additional information was obtained: on (b)(6)2020, the patient presented for a renal transplant evaluation.A cardiac catheterization was performed revealing ostial left anterior descending (lad) and distal left main (lm) stenosis.There was a known ostial lad in-stent restenosis of an unspecified stent.Reportedly, the proximal lad 4.0x15mm xience sierra stent remained patent without a device malfunction.This new information revealed that there was no complaint against this device.
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 ischemia 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: 10479619
• Report Number: 2024168-2020-07281
• Device Sequence Number: 2880393
• Product Code: NIQ
• UDI-Device Identifier: 08717648227493
• UDI-Public: 08717648227493
• 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,Followup
• Report Date (Section B): 11/18/2020

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: 10/21/2019
• Device Model Number: 1550400-15
• Device Catalogue Number: 1550400-15
• Device Lot Number: 8101641
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 10/12/2020; 10/28/2020
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 10/21/2020; 11/18/2020
• 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: 70 YR
• Patient Weight: 61