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

Model Number	1125300-33
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Cardiac Enzyme Elevation (1838); Perforation (2001); Pseudoaneurysm (2605)
Date of Event	12/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Estimated dates.The device was not returned for evaluation.A review of the lot history record of the reported device could not be conducted because the lot number was not provided.The reported patient effects of angina, perforation and pseudoaneurysm are listed in the xience alpine everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, 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.Article attached titled: "systematic review of the evaluation and management of coronary pseudoaneurysm after stent implantation".
Event or Problem Description
Details are listed in the attached article, titled ¿systematic review of the evaluation and management of coronary pseudoaneurysm after stent implantation".It was reported that the patient presented with a posterior st-elevation myocardial infarction from occlusion of the proximal circumflex artery 2 months prior to presentation.The patient underwent emergent percutaneous coronary intervention (pci) complicated by a dissection and perforation after multiple attempts to predilate a severely calcified lesion with semi-compliant, noncompliant, and cutting balloons.A 3.0x33mm xience alpine stent was implanted with timi 3 flow.The patient was discharged home on dual anti-platelet therapy.Two months later, the patient presented to the emergency department with chest pain.Troponin i was elevated (9.96 ng/ml; normal 0¿1 ng/ml).Angiography showed circumflex stent with large filling defect throughout its course with timi 3 flow.There was a dye stain observed outside the limit of vessel suggesting a contained perforation.Balloon angioplasty with a 3.0×15mm unspecified non-compliant balloon resulted in residual 50% stenosis but with resolution of the filling defect.Optical coherence tomography (oct) showed a large space outside the stent with loss of vessel continuity compatible with a pseudoaneurysm (psa).Intravascular ultrasound (ivus) of the same area suggested loss of vessel wall integrity and a large empty space behind the stent struts consistent with a psa.Ivus imaging showed blood flow outside the margin of the vessel.Based on ivus imaging, there was concern the psa extended up to left main coronary artery.As such, it was decided to defer pci using a covered stent and consider future bypass surgery if intervention was required.Because of the uncertainty as to the extent of the psa, it was decided to perform ct coronary angiogram which showed contrast outside the margin of the stent, but the size of the aneurysm was difficult to ascertain.In view of the patient's asymptomatic status and possible involvement of the left main coronary artery, it was decided to manage the patient by following serial ct coronary angiograms with plans to intervene, likely with surgery, if the psa enlarged.Patient had a follow-up ct coronary angiogram 4 months later that showed stable psa size.The patient remained asymptomatic and stable 6 months since the diagnosis of psa.No additional information was provided.

• Brand Name: XIENCE ALPINE 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: 10731353
• Report Number: 2024168-2020-08888
• Device Sequence Number: 3312867
• Product Code: NIQ
• UDI-Device Identifier: 08717648199387
• UDI-Public: 08717648199387
• Combination Product (Y/N): Y
• Initial Reporter State: AR
• 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: literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/23/2020

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 Model Number: 1125300-33
• Device Catalogue Number: 1125300-33
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 10/23/2020
• 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: 71 YR