MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REBEL; STENT, CORONARY

Model Number	10273
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	Death (1802)
Date of Event	08/07/2020
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient died.A 20 x 2.75 rebel bms stent was selected for use.The device was inserted in the artery and was pulled out.However, the stent mangled and slipped on the balloon.Once the device was outside the patient's body, the stent fell off.The procedure was completed with a different device.But, the patient died.

• Brand Name: REBEL
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10473378
• Report Number: 2134265-2020-11162
• Device Sequence Number: 19540225
• Product Code: MAF
• UDI-Device Identifier: 08714729843849
• UDI-Public: 08714729843849
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P130030
• 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
• Report Date (Section B): 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/20/2020
• Device Model Number: 10273
• Device Catalogue Number: 10273
• Device Lot Number: 0021540329
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 08/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death