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

Catalog Number 1500250-12

Device Problem Failure to Advance (2524)

Patient Problems Cardiac Arrest (1762); Tachycardia (2095); Prolapse (2475)

Event Date 12/21/2020

Event Type  Injury  

Manufacturer Narrative

Reportedly, the device is not returning for analysis.Investigation is not complete.A follow-up report will be submitted with all additional relevant information.The additional xience sierra device referenced is filed under a separate medwatch report number.

Event Description

It was reported that on (b)(6) 2020, a percutaneous coronary intervention (pci) was performed on multiple calcified lesions within the left anterior descending (lad) coronary artery.Pre-dilatation was performed.Following, both a 2.5x12mm (1500250-12, 9060441) and 2.25x8mm (1500225-08, 9050341) xience sierra stent delivery systems failed to cross the lesion mid-distal lad.Reportedly, the patient had calcified lesions throughout the lad.It was decided to abort the procedure.The patient was transferred to the critical care unit for monitoring.Shortly after arrival, the patient went into ventricular tachycardia, cardiac arrest, and was sent for emergency coronary artery bypass graft (cabg) placement.Reportedly, it was possible that some microvascular tissue or plaque disruption occurred due to the failure to crosses.The exact cause of the event was uncertain.No additional information was provided regarding this issue.

Manufacturer Narrative

The device was not 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 other incidents from this lot.It should be noted that the reported patient effects of cardiac failure (cardiac arrest), cardiac arrhythmias (tachycardia) and prolapse are listed in the xience sierra everolimus eluting coronary stent systems instructions for use as known patient effects of coronary procedures.The investigation determined the reported failure to advance appears to be related to circumstances of the procedure as it is likely that resistance was met with the heavily calcified anatomy resulting in the reported failure to advance.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE SIERRA 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: 11339802
• MDR Text Key: 232257125
• Report Number: 2024168-2021-01265
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2022
• Device Catalogue Number: 1500250-12
• Device Lot Number: 9060441
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Disability