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

Model Number 1125275-18

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Atrial Fibrillation (1729); Dyspnea (1816); Cardiac Enzyme Elevation (1838); Ischemia (1942); Heart Failure (2206); Test Result (2695)

Event Date 11/08/2019

Event Type  Injury  

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 Description

Patient id: (b)(6).It was reported that a percutaneous coronary intervention was performed on (b)(6) 2019.A 2.75x18mm xience alpine stent was implanted in the proximal-mid left anterior descending (lad) coronary artery lesion and a 2.5x12mm xience alpine stent was implanted in the mid lad.The procedure was performed without complications.Starting on (b)(6) 2019, the patient experienced acute on chronic heart failure.The patient was admitted to the hospital with dyspnea, orthopnea, and angina.Elevated troponin and the ejection fraction was observed at 50-55%.Reportedly, the elevated troponin was related to demand ischemia secondary to heart failure and atrial fibrillation.Medications were provided.On (b)(6) 2019, a non-abbott stent was implanted in the stenosed proximal lad, more proximal and slightly overlapping the previously implanted mid-proximal lad 2.75x18mm xience alpine stent.Medications were also provided.Per physician, the events were unrelated to the xience alpine stents and unrelated to the index procedure.There was no device malfunction.The event resolved without sequela.There was no additional information provided regarding this issue.

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(s) of angina, ischemia and atrial fibrillation are listed in the xience alpine everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary stenting 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.

• Brand Name: XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9935627
• MDR Text Key: 187392697
• Report Number: 2024168-2020-03476
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648199264
• UDI-Public: 08717648199264
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2020
• Device Model Number: 1125275-18
• Device Catalogue Number: 1125275-18
• Device Lot Number: 7041761
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Weight: 79