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

Model Number 1550225-38

Device Problems Difficult to Insert (1316); Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number e2019001.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a 90% stenosed, heavily tortuous, and heavily calcified de novo lesion in the proximal left anterior descending coronary artery.Reportedly, a 2.25x38mm xience sierra stent delivery system (sds) was attempted to be advanced with a non-abbott guide extension catheter; however, the sds could not be inserted into the guide extension catheter due to interaction with the non-abbott guide extension catheter.Therefore, the non-abbott guide extension catheter was replaced with a 5.5fr non-abbott guide extension catheter.Although resistance was noted due to heavy tortuosity, the sds was advanced with the extension catheter and the stent was deployed.When the sds was removed, strong resistance was noted with 5.5 fr extension catheter.While the sds was pulled out carefully, the sds became detached into 2 pieces around the mid shaft.The distal detached part remained inside the guiding catheter; therefore, the distal part was retrieved by snare device.No parts remained inside the anatomy.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported material separation was able to be confirmed.The reported difficult to advance was unable to be replicated in a testing environment as it was based on operational circumstances.The reported difficult to insert and difficult to remove were unable to be replicated in a testing environment due to the condition of the returned device.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 similar incidents from this lot.The majority of the time the resistance with the guiding catheter is either because the sds is not coaxially aligned, meaning its not inserted straight, so it interacts with the guiding catheter, or the shape of the anatomy can angle the guiding catheter such that the sds bumps into it, causing resistance.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the non-abbott guide extension catheter resulted in the reported difficult to insert.Resistance was then met with the 90% stenosed, heavily tortuous, and heavily calcified anatomy and/or the resulting in the reported difficult to advance.During removal interaction with the guiding catheter resulted in the reported difficult to remove.Manipulation of the device ultimately resulted in the reported shaft separation.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 9549236
• MDR Text Key: 177016593
• Report Number: 2024168-2020-00247
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227066
• UDI-Public: 08717648227066
• Combination Product (y/n): N
• 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: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2021
• Device Model Number: 1550225-38
• Device Catalogue Number: 1550225-38
• Device Lot Number: 808044A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Date Manufacturer Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE EXTENSION CATHETER: KIWAMI, 5.5F GUIDELINER
• Patient Outcome(s): Required Intervention