MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1070350-48

Device Problems Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/31/2021

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a moderately calcified and moderately tortuous lesion in the left anterior descending (lad) coronary artery.Pre-dilatation was performed using a non-abbott balloon.The 3.5x48mm xience xpedition stent delivery system (sds) was able to cross the lesion without resistance and the stent was deployed successfully at nominal pressure.There were no deflation issues, however, upon removal of the sds, it was found that the distal tip of the balloon was stuck at the guiding catheter tip.After a few attempts to remove the sds with force applied, it was found that the delivery shaft was broken into 2 separate pieces.The proximal half of the sds was pulled out from the guiding catheter independently.The distal half of the sds was retrieved by pulling the whole guiding catheter system out.There was no adverse patient effect and there was no significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).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.

Manufacturer Narrative

A visual inspection was performed on the returned device.The reported difficult to remove could not be tested due to the condition of the 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 similar incidents from this lot.It was reported that force was applied to the stent delivery system (sds) during removal of the device from the anatomy.It should be noted that the xience xpedition instructions for use (ifu) states: applying excessive force to the delivery system can potentially result in loss or damage to the stent and/or delivery system components.In this case, it is unknown if the ifu deviation contributed to the reported event.The investigation determined the reported difficulties are related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: XIENCE XPEDITION 48 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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12828536
• MDR Text Key: 280890818
• Report Number: 2024168-2021-10467
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: MY
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2024
• Device Catalogue Number: 1070350-48
• Device Lot Number: 1032241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDING CATHETER