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

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ventricular Fibrillation (2130); Perforation of Vessels (2135); Cardiac Tamponade (2226)

Event Date 01/01/2023

Event Type  Injury  

Event Description

It was reported that coronary perforation occurred and patient experienced cardiac tamponade and ventricular fibrillation.The stenosed target lesion was located in the severely calcified proximal left anterior descending artery.A rotablator burr was selected for use.During the procedure, extravasation of contrast medium was observed after the passage of the rotaburr.Immediately, the perfusion balloon was dilated at the left anterior descending proximal site.However, the bleeding could not stop.Consequently, the blood pressure decreased due to cardiac tamponade and ventricular fibrillation occurred.Drainage was attempted but it could not be achieved.Venoarterial extracorporeal membrane oxygenation (v-a ecmo) was introduced.Intravascular ultrasound (ivus) findings showed that the vessel wall on the left circumflex side disappeared from the left main trunk to the proximal left anterior descending artery, and there was no connection between the left circumflex and the main trunk.A covered stent crossing over the left circumflex was necessary to stop the bleeding.A covered stent was placed from left main trunk to left anterior descending artery.After stenting, bleeding stopped, and patient's condition has improved.Patient was transferred to another hospital for coronary artery bypass graft (cabg).

Manufacturer Narrative

Date of event: (b)(6) 2023 was used as an approximate event date, as the actual event date is unknown.

Manufacturer Narrative

Date of event: 01/01/2023 was used as an approximate event date, as the actual event date is unknown.

Event Description

It was reported that coronary perforation occurred and patient experienced cardiac tamponade and ventricular fibrillation.The stenosed target lesion was located in the severely calcified proximal left anterior descending artery.A rotablator burr was selected for use.During the procedure, extravasation of contrast medium was observed after the passage of the rotaburr.Immediately, the perfusion balloon was dilated at the left anterior descending proximal site.However, the bleeding could not stop.Consequently, the blood pressure decreased due to cardiac tamponade and ventricular fibrillation occurred.Drainage was attempted but it could not be achieved.Venoarterial extracorporeal membrane oxygenation (v-a ecmo) was introduced.Intravascular ultrasound (ivus) findings showed that the vessel wall on the left circumflex side disappeared from the left main trunk to the proximal left anterior descending artery, and there was no connection between the left circumflex and the main trunk.A covered stent crossing over the left circumflex was necessary to stop the bleeding.A covered stent was placed from left main trunk to left anterior descending artery.After stenting, bleeding stopped, and patient's condition has improved.Patient was transferred to another hospital for coronary artery bypass graft (cabg).

• 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: 17744283
• MDR Text Key: 323385028
• Report Number: 2124215-2023-49045
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/02/2023

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 09/14/2023
• Supplement Dates Manufacturer Received: 09/14/2023
• Supplement Dates FDA Received: 10/02/2023
• 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: 60 YR
• Patient Sex: Female