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

Model Number 1074400-38

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

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 07/14/2020

Event Type  malfunction  

Manufacturer Narrative

The device location was not provided, and it is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the 4.0x38 mm xience xpedition stent came out when the protective sheath and stylet were removed with some resistance noted.There was no reported patient involvement and there was no reported device use.There was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

H6: 2017 failure to follow steps/instructions a visual and dimensional inspection was performed on the returned device.The reported stent dislodgement was confirmed.The reported difficult to remove could not be tested based on the condition of the returned device.It should be noted that the xience xpedition, everolimus eluting coronary stent system, instructions for use (ifu) states: prior to using the xience xpedition, everolimus eluting coronary stent system, carefully remove the system from the package and inspect for bends, kinks, and other damage.Verify that the stent does not extend beyond the radiopaque balloon markers.Do not use if any defects are noted.The ifu deviation does not appear to have directly caused or contributed to the reported difficulties.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 circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6: patient code 2645 was removed.

Event Description

Returned device analysis and confirmation with the account identified that the delivery system had been inserted into the patient.The dislodged stent was found on the stylet wire.There were no adverse patient effects.No additional information was provided.

• Brand Name: RX XPEDITION LL
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10368063
• MDR Text Key: 202053325
• Report Number: 2024168-2020-06522
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648162688
• UDI-Public: 08717648162688
• 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: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2023
• Device Model Number: 1074400-38
• Device Catalogue Number: 1074400-38
• Device Lot Number: 0010241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1