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

Device Problem Failure to Advance (2524)

Patient Problems Cardiac Arrest (1762); Myocardial Infarction (1969)

Event Date 08/01/2023

Event Type  Injury  

Event Description

It was reported that no flow, cardiopulmonary arrest and myocardial infarction occurred.The patient presented with angina and admitted to the hospital for a percutaneous coronary intervention (pci) of the right coronary artery (rca) and left circumflex artery (lcx).Coronary artery angiography (cag) revealed chronic total occlusion (cto) of rca with collateral from lcx and severe stenosis of left anterior descending (lad) and lcx.It was performed ad hoc pci to lcx, followed by staged pci to lad.Intravascular ultrasound (ivus) showed a short but thick calcified lesion, so it was performed rotational ablation with a 1.75mm rotablator burr, but the burr did not pass the lesion and cag showed a no-flow phenomenon in the lad.The patient went into cardiopulmonary arrest, and it was inserted percutaneous cardiopulmonary support (pcps) and intra-aortic balloon pumping (iabp).Then, it was attempted to dilate the lesion with a non-compliant balloon and cutting balloon, but could not achieve dilation, so it was performed orbital atherectomy.However, the lesion did not dilate with a balloon even after ablation with orbital atherectomy system (oas), and the physicians decided to perform coronary artery bypass graft (cabg) at a later date.The patient was able to wean off pcps quickly without elevation of creatine kinase (ck) but developed acute broad anterior myocardial infarction 10 days later.Performed primary pci and obtained reperfusion, but the lesion was still not dilated, so cabg performed at a later date.In opinion of the physicians, a diffuse lesions, small vessels, and severe angulation that showed no flow after ablation and subsequently developed myocardial infarction.

Manufacturer Narrative

B3: date of event: it was not provided, used the first date of the month of the aware date."(b)(4) a case of short segment calcified lesion with no flow and no extension of the lesion by rotablator" was on a poster presentation at a conference on complications-5, saturday, (b)(6) 2023, in (b)(6).

• 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 CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17701634
• MDR Text Key: 322875699
• Report Number: 2124215-2023-48658
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male