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

Model Number	10273
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	02/28/2019
Type of Reportable Event	Death
Event or Problem Description
It was reported that death occurred.The 90% stenosed target lesion was located in the left anterior descending artery (lad).The patient was scheduled for a planned percutaneous coronary intervention (pci) procedure as the patient was turned down by surgeon for bypass surgery.A 3.0 x 20 synergy stent was placed in the distal lad, a 3.5 x 38 synergy stent was then placed in the mid lad, and then a 3.5 x 16 synergy stent was placed in the proximal lad.A final angiogram image showed good blood flow and the procedure was finished.While the patient was in recovery, the patient coded thirty minutes post procedure and was then brought back to the cath lab.At that time, it was discovered that the three synergy stents had closed down.The lad was thrombosed up to the proximal edge of the 3.5 x 16 synergy stent.The physician wired and then ballooned the distal to proximal lad and then implanted a 20 x 3.5 rebel stent balloon in the proximal segment of the lad.A non bsc aspiration catheter device was also used to restore blood flow.An additional 10,000 units of heparin were given along with other medications.The patient expired at the end of the second procedure while still in the cath lab.

• Brand Name: REBEL
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8451879
• Report Number: 2134265-2019-02902
• Device Sequence Number: 240173
• Product Code: MAF
• UDI-Device Identifier: 08714729843863
• UDI-Public: 08714729843863
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P130030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/12/2020
• Device Model Number: 10273
• Device Catalogue Number: 10273
• Device Lot Number: 0020884131
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 03/26/2019
• 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: Death