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

Model Number 1550400-23

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat the left main artery.Two guide wires were already placed in the anatomy.As the 4x23mm xience sierra was being advanced and reached the guiding catheter, the physician noted that the proximal portion of the device felt loose.It was decided to remove the device.Once removed completely the proximal shaft separated.No force or resistance was noted at any time.Another same size xience sierra was used to succcessfully complete the procedure.There was no adverse patient effects or clinically significant delay.No additional information was provided.

Manufacturer Narrative

A visual inspection was performed on the returned device.The reported material separation was confirmed.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.The investigation determined the reported material separation appears to be related to circumstances of the procedure, as it is likely the device interacted with accessory devices during advancement resulting in the reported material separation.Manipulation of the device during advancement likely contributed to the noted bent, flared and stretched stent struts, kinked/wrinkled inner/outer member and bent skive.Further manipulation of the device during retraction likely contributed to the noted stretched and torn guide wire exit notch.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• Brand Name: XIENCE SIERRA
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10555372
• MDR Text Key: 207719150
• Report Number: 2024168-2020-07835
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227516
• UDI-Public: 08717648227516
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2021
• Device Model Number: 1550400-23
• Device Catalogue Number: 1550400-23
• Device Lot Number: 0051141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 6 FR SHEATH