MAUDE Adverse Event Report: ABBOTT VASCULAR ULTRA RX; CORONARY STENT DELIVERY SYSTEM

Model Number	1003381-18
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that prior to use, the stent of a 4.5x18mm multilink ultra stent delivery system (sds) was dislodged and remained in the protective sheath.The device was not used and there was no patient involvement.An unspecified stent was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional 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 other incidents.The investigation was unable to determine a conclusive cause for the reported stent dislodgement.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.Na.

• Brand Name: ULTRA RX
• Common Device Name: CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10292641
• Report Number: 2024168-2020-05963
• Device Sequence Number: 11668642
• Product Code: MAF
• UDI-Device Identifier: 08717648035272
• UDI-Public: 08717648035272
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P970020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

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: 01/31/2021
• Device Model Number: 1003381-18
• Device Catalogue Number: 1003381-18
• Device Lot Number: 9021441
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1