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

Model Number	10276
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that deployment was unsuccessful and stent snaring was required.A 32 x 3.00 rebel stent was advanced for treatment.The stent was delivered; however, it was not successfully deployed and had to be snared for retrieval by a vascular surgeon.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a rebel bms catheter.The balloon was loosely folded with the stent separated.The hypotube, outer shaft, inner shaft, balloon, stent and tip were visually and microscopically examined.There were numerous hypotube and shaft kinks.The tip was damaged.The separated stent was severely damaged.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that deployment was unsuccessful and stent snaring was required.A 32 x 3.00 rebel stent was advanced for treatment.The stent was delivered; however, it was not successfully deployed and had to be snared for retrieval by a vascular surgeon.No patient complications were reported.

• Brand Name: REBEL
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8659188
• Report Number: 2134265-2019-05694
• Device Sequence Number: 2662690
• Product Code: MAF
• UDI-Device Identifier: 08714729844068
• UDI-Public: 08714729844068
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 07/02/2019

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: 10/18/2021
• Device Model Number: 10276
• Device Catalogue Number: 10276
• Device Lot Number: 0022816346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 07/02/2019
• 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: Required Intervention