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

Model Number 1074250-38

Device Problems Difficult to Remove (1528); Stretched (1601); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

Patient Problem No Patient Involvement (2645)

Event Date 07/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that during removal of the protective sheath from the 2.5x38mm rx xience xpedition drug eluting stent (des), resistance was noted and force was applied.The stent elongated on the balloon and became stuck in the protective sheath.There was no patient involvement and no clinically significant delay in the procedure.Another unspecified device was used to complete the procedure.No additional information was provided.

Event Description

Subsequent to the initial 30-day medwatch report, the following information was provided: the stent remained stuck in the protective sheath and came off of the balloon.

Manufacturer Narrative

A visual and dimensional inspection was performed on the returned device.The reported stent dislodgement and stretched stent was confirmed.The reported difficult to remove from the protective sheath could not be tested 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 incidents.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.

• Brand Name: XIENCE XPEDITION 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
• MDR Report Key: 10427968
• MDR Text Key: 203825411
• Report Number: 2024168-2020-06929
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648162183
• UDI-Public: 08717648162183
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2022
• Device Model Number: 1074250-38
• Device Catalogue Number: 1074250-38
• Device Lot Number: 9093041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Date Manufacturer Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1