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

Model Number	10275
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Date of Event	10/23/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a shaft break, unretrieved device fragments, and surgical intervention occurred.During a peripheral case, a 28mm x 4.00mm rebel stent balloon expandable was used for treatment, but the stent became stuck in the artery.The stent stripped off the device, the shaft was separated, and was left inside the patient.The patient was sent to surgery for the unretrieved device fragment.The procedure was completed and no additional patient complications were reported in relation to this event.
Event or Problem Description
It was reported that a shaft break, unretrieved device fragments, and surgical intervention occurred.During a peripheral case, a 28mm x 4.00mm rebel stent balloon expandable was used for treatment, but the stent became stuck in the artery.The stent stripped off the device, the shaft was separated, and as left inside the patient.The patient was sent to surgery for the unretrieved device fragment.The procedure was completed and no additional patient complications were reported in relation to this event.It was later reported that the target lesion was located in superficial femoral artery (sfa) and over the arch.It was noted that the reason for the event was likely due to calcifications in the vessel and the angle of the purchase in the arch.The event likely occurred while advancing the device and became stuck.It was additionally noted that while pulling back the wire, it likely bent over at the end of the deployment catheter and then rubbed on the edge of a calcification.The detached portion was surgically removed from the patient.A cut down was done in the operating room (or) under anesthesia, the wire section was removed, and the patient was closed up.No additional patient complications were reported in relation to this event.It was later reported that the patient presented as an outpatient, scheduled as an arteriogram with runoff.Following the image evaluation, and consultation with the ordering physician, it was determined that a stent would be placed at a stenosis proximal of the level of the knee.While advancing the stent over through a sheath, a point was reached to where the stent would not advance freely.While retracting the stent delivery system, the entire delivery system detached from the catheter.The wire with the stent fractured, leaving behind an approximately six inch section of wire and tent.Attempts to retrieve the stent delivery system were unsuccessful.The provider called the vascular surgeon on call and discussed and the patient was planned for surgical removal of the remaining piece.The patient went to the operating room and had a cut down done and the wire and stent were retrieved intact without problems.No additional patient complications were reported in relation to this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the returned product consisted of a rebel bms balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 103.6cm distal of the strain relief.There was blood in the guidewire lumen.The balloon was tightly folded.The stent was in place and there was no damage to the stent.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported broken shaft as the hypotube was separated.
Event or Problem Description
It was reported that a shaft break, unretrieved device fragments, and surgical intervention occurred.During a peripheral case, a 28mm x 4.00mm rebel stent balloon expandable was used for treatment, but the stent became stuck in the artery.The stent stripped off the device, the shaft was separated, and as left inside the patient.The patient was sent to surgery for the unretrieved device fragment.The procedure was completed and no additional patient complications were reported in relation to this event.It was later reported that the target lesion was located in superficial femoral artery (sfa) and over the arch.It was noted that the reason for the event was likely due to calcifications in the vessel and the angle of the purchase in the arch.The event likely occurred while advancing the device and became stuck.It was additionally noted that while pulling back the wire, it likely bent over at the end of the deployment catheter and then rubbed on the edge of a calcification.The detached portion was surgically removed from the patient.A cut down was done in the operating room (or) under anesthesia, the wire section was removed, and the patient was closed up.No additional patient complications were reported in relation to this event.It was later reported that the patient presented as an outpatient, scheduled as an arteriogram with runoff.Following the image evaluation, and consultation with the ordering physician, it was determined that a stent would be placed a stenosis proximal of the level of the knee.While advancing the stent over through a sheath, a point was reached to where the stent would not advance freely.While retracting the stent delivery system, the entire delivery system detached from the catheter.The wire with the stent fractured, leaving behind an approximately six inch section of wire and tent.Attempt to retrieve the stent delivery system were unsuccessful.The provider called the vascular surgeon on call and discussed and patient was planned for surgical removal of the remaining piece.Patient went to operating room and had a cut down done and wire and stent were retrieved intact without problems.No additional patient complications were reported in relation to this event.

• Brand Name: REBEL
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10852480
• Report Number: 2134265-2020-15911
• Device Sequence Number: 2420008
• Product Code: MAF
• UDI-Device Identifier: 08714729844013
• UDI-Public: 08714729844013
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: P130030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/04/2021

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: 04/24/2022
• Device Model Number: 10275
• Device Catalogue Number: 10275
• Device Lot Number: 0023692069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2020
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 11/18/2020; 01/14/2021
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 12/04/2020; 02/04/2021
• 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
• Patient Age: 76 YR