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

Catalog Number 1070225-12

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number (b)(4) permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.

Event Description

It was reported the procedure was to treat a lesion in the left anterior descending (lad) artery.The 2.25x12mm rx xience xpedition stent delivery system (sds) was advanced to the lesion and the stent deployed.After deployment, the balloon could not be removed from the stent.Several attempts were made and the balloon was finally able to be removed.It was noted negative was not applied for 30 seconds to deflate to the balloon.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Event Description

Subsequent to the initially filed medwatch, additional information was received.The balloon was fully deflated prior to retraction.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 similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the deployed stent during removal causing the reported difficulty to remove.The device was able to be removed after several attempts, however; it should be noted the device was pulled negative for approximately 3-5 seconds and not the recommended 30 seconds instructed in the xience xpedition instructions for use which may have contributed the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design or labeling.Removed code 2017.Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.Correction: device code 2017 removed.

• Brand Name: XIENCE XPEDITION
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8819478
• MDR Text Key: 152058309
• Report Number: 2024168-2019-10272
• Device Sequence Number: 1
• Product Code: NIQ
• 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: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2021
• Device Catalogue Number: 1070225-12
• Device Lot Number: 8061841
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1