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

Model Number	1550275-33
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	07/06/2020
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 of intimal dissection is listed in the xience sierra everolimus eluting coronary stent system instructions for use as known patient effect of coronary stenting procedures.Based on the information reviewed, there is no indication of a product quality issue.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 of the device.The additional xience sierra device referenced is filed under a separate medwatch report number.
Event or Problem Description
Patient id: (b)(6).It was reported that on (b)(6) 2020, the patient presented with a recent non-st elevated myocardial infarction (nstemi), elevated troponin, and a percutaneous coronary intervention was performed.Pre-dilatation was performed on the mid left anterior descending (lad) coronary artery lesion and a 2.75x33mm xience sierra stent (1550275-33, 0011041) was implanted.An edge dissection was observed, treated with a 3.0x33mm xience sierra stent (1550300-33, 0021841).Post-dilatation was performed on the 3.0x33mm xience sierra stent when a plaque shift with 100% occlusion occurred in the proximal diagonal coronary artery.Additional angioplasty was performed as treatment.Reportedly, there was no device malfunction and the event resolved.Post-procedure results were acceptable, 0% residual diameter stenosis and timi flow iii.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: 10338703
• Report Number: 2024168-2020-06278
• Device Sequence Number: 14223970
• Product Code: NIQ
• UDI-Device Identifier: 08717648227219
• UDI-Public: 08717648227219
• 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): 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/16/2021
• Device Model Number: 1550275-33
• Device Catalogue Number: 1550275-33
• Device Lot Number: 0011041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 07/29/2020
• 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: 63 YR
• Patient Weight: 102