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

Model Number	1007850-15
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During advancement of the stent, the shaft of the stent broke outside of the body.The stent was pulled out and was not delivered.A new stent was pulled and placed without difficulty.Manufacturer response for coronary stent, multi-link vision (per site reporter).Unknown at this time.Returning it to manufacturer.

• Brand Name: MULTI-LINK VISION
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054
• MDR Report Key: 7946303
• Report Number: 7946303
• Device Sequence Number: 930904
• Product Code: MAF
• UDI-Device Identifier: 08717648050787
• UDI-Public: (01)08717648050787
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/28/2018
• Report Date (Section F): 09/28/2018

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: 1007850-15
• Device Catalogue Number: 1007850-15
• Device Lot Number: 7031541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 93
• Date Report Sent to FDA: 09/28/2018