MAUDE Adverse Event Report: ABBOTT VASCULAR INC. MULTI-LINK ULTRA; STENT, CORONARY

Model Number	1003382-18
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/14/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Stent came off the end of the balloon and wire as it was being inserted in the celiac.The celiac artery was approached last.Despite multiple attempts at advancing the 7 french oscor conformable sheath this was unsuccessful in providing enough support to advance a 5 x 19 mm gore v bx stent.With repeat attempt using an 8.5 french oscor conformable sheath, wire access to the celiac artery was lost.

• Brand Name: MULTI-LINK ULTRA
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054
• MDR Report Key: 7665930
• Report Number: 7665930
• Device Sequence Number: 11420445
• Product Code: MAF
• UDI-Device Identifier: 08717648035319
• UDI-Public: (01)08717648035319(17)190930(10)7102541(91)3489
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2018
• Report Date (Section F): 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1003382-18
• Device Catalogue Number: 1003382-18
• Device Lot Number: 7102541
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 69
• Date Report Sent to FDA: 06/29/2018