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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiogenic Shock (2262)

Event Date 08/01/2023

Event Type  Death  

Manufacturer Narrative

A2: age at time of event: 80's (octogenarian).B2: date of death: the date of death was note reported.B3: date of event: it was not provided, used the first date of the month of the aware date."(b)(4) a case of stemi due to lad stenosis with severe calcification, resulting in slow flow by a large size rota" was on a poster presentation at a conference on acs pci, friday, (b)(6) 2023, in (b)(6).

Event Description

It was reported that a slow flow occurred after ablation and the patient died.The patient presented with a chest pain showed st elevation and acute decongestive heart failure, and emergent coronary artery angiography (cag) demonstrated a stenosed coronary with severely calcified middle left anterior descending artery (lad).After intra-aortic balloon pump (iabp) insertion, primary percutaneous coronary intervention (pci) was performed.Although only a small balloon passed the culprit lesion, the balloon ruptured due to calcification.Intravascular ultrasound (ivus) elucidated diffuse successive heavy calcification from proximal to middle part of lad, so elective pci with the debulking system was planned.Because timi 3 flow was obtained just using balloon dilatation, the physicians terminated the primary pci.Although uncontrollable heart failure was sustained, her femoral artery was so small that the impella system was unsuitable.Then semi-urgent second pci was performed.Afterwards, the calcification was debulked using a 1.50mm rotablator burr.After rota ablation, ivus and oct elucidated the residual calcification in the whole lad lesion.A 2.0mm rotablator burr was selected to obtain further calcification ablation.However, fatal slow flow occurred after ablation, and vital status collapsed.Percutaneous cardiopulmonary support (pcps) inserted and deployed drug-eluting stents (des) at the culprit lesion; the coronary flow was obtained.The patient died due to cardiogenic shock days later.

• 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: 17701905
• MDR Text Key: 322878513
• Report Number: 2124215-2023-48671
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 09/07/2023
• 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): Death
• Patient Sex: Female