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	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	02/11/2018
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.The additional device referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that on (b)(6) 2018, the patient presented due to an acute myocardial infarction (ami).Due to the presence of thrombus, aspiration was performed and then two xience alpine stents (3.5x23mm, 3.0x33mm) were implanted in the mid to proximal left anterior descending (lad) artery.Reportedly, the overlapped section was not well apposed to the vessel wall, and post dilatation was attempted but unable to be performed due to the slow blood flow, resulting in some ischemia and timi flow only 2.5.Dual antiplatelet therapy was given.On (b)(6) 2019, dapt was discontinued but the patient continued to take aspirin.On (b)(6) 2021, the patient was hospitalized due to an ami.The 3.5x23mm xience alpine stent was noted to be 100% occluded with thrombus.The thrombus was aspirated.A non-abbott stent was implanted followed by post dilatation.Intravascular ultrasound (ivus) was performed confirming good wall apposition of all 3 stents.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The reported patient of ischemia is listed in the xience alpine everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported patient-device incompatibility (wall apposition); however, factors that may contribute to difficulty to deploy (wall apposition) include, but are not limited to, interaction with challenging anatomy and insufficient post-dilation.The reported patient effect of ischemia and unexpected medical intervention appear to be related to operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Additional Manufacturer Narrative
The device was not returned for analysis.H10: addtl mfg narrative: correction from: "the device was returned for analysis." to "the device was not returned for analysis.".

• 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: 12147353
• Report Number: 2024168-2021-05906
• Device Sequence Number: 4215827
• Product Code: NIQ
• UDI-Device Identifier: 08717648199387
• UDI-Public: 08717648199387
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/21/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/27/2020
• Device Model Number: 1125300-33
• Device Catalogue Number: 1125300-33
• Device Lot Number: 7071741
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2021
• Supplement Date Received by Manufacturer: 07/12/2021; 09/16/2021
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 07/21/2021; 09/21/2021
• 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: 74 YR
• Patient Weight: 68