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

Catalog Number 1550250-38

Device Problems Defective Device (2588); Component Misassembled (4004)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.The customer reported the device was discarded.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 performed to treat a non-calcified, non-tortuous de novo lesion in the distal right coronary artery.Although the 2.5x38mm xience sierra stent was deployed in the target lesion, the placement of the balloon markers was off in relation to the balloon shoulder.Per the physician, the distance between the proximal end of the balloon shoulder and the proximal marker was too long.The physician suspected that the balloon had been assembled incorrectly during the manufacturing process.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

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.The investigation was unable to determine a conclusive cause for the reported defective device and component misassembled.It should be noted a still shot image was received for review; however, the image as provided and without further details, does not provide enough detail to confirm the reported complaint.The image appears to be foreshortened which would make the markers appear further from the balloon shoulder in the proximal portion versus the distal portion.Foreshortening occurs when the x-ray beam is not perfectly perpendicular to the object (in this case the balloon).Additionally, the deployment pressure and/or pressure in the balloon when this picture was taken is not indicated and this can also affect placement of the markers compared to the balloon shoulders.The markers are fixed on the catheter shaft and when a balloon is expanded above nominal pressure the balloon can grow longitudinally (usually more in the proximal portion).This could move the balloon shoulder to a location outside of the balloon markers by a variable difference depending on the pressure in the balloon.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: 9411083
• MDR Text Key: 177764246
• Report Number: 2024168-2019-14111
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227141
• UDI-Public: 08717648227141
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2021
• Device Catalogue Number: 1550250-38
• Device Lot Number: 810084A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1