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

Catalog Number 1009527-23E

Device Problems Difficult to Remove (1528); Material Separation (1562); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.The other everlink device referenced is filed under a separate medwatch report number.The everlink device is an abbott vascular manufactured device which is distributed in (b)(6).Though this device is not commercially available for sale in the usa, it is similar to a device currently marketed for sale in the usa.

Event Description

It was reported that the procedure was to treat lesions located in the heavily tortuous mid to proximal left anterior descending coronary artery that were heavily calcified and 90% stenosed.An extension catheter (gc) was used to add support for the everlink stent delivery system (sds) to reach the lesion but the sds failed to cross into the lesion.During removal of the sds, the shaft broke in two pieces inside the gc.All was removed as a single unit.A second everlink sds was advanced, but also failed to cross the lesion and during removal, the shaft separated.It was thought that the two sds's may have separated in two due to the vessel characteristics and an interaction between the gc and the stent system.There was no reported adverse patient effect or a clinically significant delay in the procedure.Two new everlink stents were implanted to complete the procedure.No additional information was provided.

Manufacturer Narrative

A visual, functional and dimensional inspection was performed on the returned device.The reported material separation and difficult to remove was not confirmed.There was no separation as reported.The stent implant was stationary on the balloon between the markers.There was no damage noted to the stent implant.The reported failure to advance could not be tested as it was based on operational circumstances.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 did not indicate a lot specific quality issue.The investigation determined the reported failure to advance appears to be related to circumstances of the procedure.The investigation was unable to determine a conclusive cause for the reported shaft detachment and difficult to remove as they could not be confirmed during return analysis testing.Based on the information reviewed and analysis of the returned device, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: EVERLINK 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: 10518269
• MDR Text Key: 219571389
• Report Number: 2024168-2020-07581
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2022
• Device Catalogue Number: 1009527-23E
• Device Lot Number: 0042841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEZILLA GUIDE EXTENSION CATHETER (GC).