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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
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.
 
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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 Key17701905
MDR Text Key322878513
Report Number2124215-2023-48671
Device Sequence Number1
Product Code MCX
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
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 Received09/07/2023
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 Number1
Patient Outcome(s) Death;
Patient SexFemale
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