MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY

Device Problem Failure to Advance (2524)

Event Date 01/29/2024

Event Type  Injury  

Event Description

Agent ide study it was reported that reduced blood flow occurred.On december 10th, 2021, a target lesion in the mid left anterior descending artery (lad) was treated with balloon angioplasty using a 2.50 x 30mm agent dcb.On january 29th, 2024 the subject presented with 90% restenosis at the mid lad.The target lesion was first treated using a non-boston scientific balloon after this, rotational atherectomy was performed using a 1.50mm rotapro burr, however the rotapro burr was unable to be advanced into the lesion.At this point the repeated angiography revealed no reflow in the lad for which further rotablation was not performed.Post this, the lesion was treated with a 2.50 x 10mm wolverine cutting balloon which was also unable to cross the stent distally.Finally, a 2.50 x 15mm nc emerge balloon was used inflated in the entire stented segment.Post which, the ivus revealed luminal gain and no edge complication, 20% residual stenosis with timi flow of 3.On january 31st, 2024, the subject was stable without any chest pain revealing stable ekg with normal evolution of mi and the subject was discharged with clopidogrel, warfarin, imdur, metop, and crestor, followed by cardiac rehabilitation.

• Brand Name: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC LTD; model farm road; cork ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18913670
• MDR Text Key: 337775334
• Report Number: 2124215-2024-15834
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female