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

Model Number	1074250-38
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/16/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10427968
• Report Number: 2024168-2020-06929
• Device Sequence Number: 2938908
• Product Code: NIQ
• UDI-Device Identifier: 08717648162183
• UDI-Public: 08717648162183
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 08/19/2020
• Supplement Report FDA Received Date: 09/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1