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

Model Number 1074300-38

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

Patient Problems Cardiac Arrest (1762); Cardiac Enzyme Elevation (1838); Occlusion (1984); Ventricular Fibrillation (2130); Prolapse (2475)

Event Date 09/16/2020

Event Type  Injury  

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.The reported patient effect(s) of ventricular fibrillation and occlusion are listed in the xience xpedition everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary procedures.A conclusive cause for the reported patient effect(s), 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.

Event Description

Patient id: (b)(6).It was reported that on (b)(6) 2020, the patient presented with in-stent restenosis with a chronic, total occlusion (100%) within the proximal right coronary artery (rca) lesion.Pre-dilatation was performed.Three 3.0x38mm xience xpedition stents were implanted and a 3.0x18mm xience xpedition stent was implanted without a device issue reported.Timi flow 3 and 0% residual stenosis was observed.Plaque shift had occurred within a xience stent and the side branch was lost.The side branch was attempted to be re-crossed unsuccessfully.The patient had gone into ventricular fibrillation, treated with cardioversion.During oct imaging, the patient went into cardiac arrest.The patients rhythm returned to normal sinus and the event resolved.Elevated cardiac enzymes were also observed without any treatment reported and without any new myocardial infarction (mi) diagnosed.Reportedly, the elevated enzymes were likely due to cardiac arrest along with loss of a side branch.The patient was kept overnight for observation.There was no device malfunction.No additional information was provided regarding this issue.

• Brand Name: XIENCE XPEDITION 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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10656302
• MDR Text Key: 210650735
• Report Number: 2024168-2020-08433
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648162381
• UDI-Public: 08717648162381
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/09/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2022
• Device Model Number: 1074300-38
• Device Catalogue Number: 1074300-38
• Device Lot Number: 9080141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2020
• Initial Date FDA Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3 IMPLANTED XIENCE XPEDITION STENTS
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 98