MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY

Model Number UNK509

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

Patient Problems Cardiac Arrest (1762); Chest Pain (1776); Occlusion (1984)

Event Date 10/27/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mfr report#: 2134265-2017-11205, 2134265-2017-11206, 2134265-2017-11207, 2134265-2017-11208.It was reported that the patient had chest pain, an occlusion and cardiac arrest.The target lesion was located in the heavily calcified ostial right coronary artery (rca).Pre-dilation was performed with a 2.5mm nc emerge balloon to 28 atms, which didn't expand the lesion.Then a 1.50mm rotablator rotalink plus burr was used.After that a 2.5x8mm non-bsc stent was implanted in the proximal rca and a 2.50x8mm synergy stent was implanted in the ostium.Post-dilation was performed with a 2.5mm nc emerge balloon to 28 atms, but never fully expended both stents.It was decided to leave it at this point.About 45 minutes later the patient had chest pain in the holding area and was brought back to the lab.The rca was found occluded and the patient arrested.Cardiopulmonary resuscitation (cpr) was started via a non-bsc chest compression system and the rca was re-wired and re-ballooned.A blood thinner was administered and then the rca had better flow and the patient stabilized.The patient was also put on extracorporeal membrane oxygenation (ecmo).The left ventricular function had improved back to 55% and the patient was "doing better".The physician attributed the event to severe stent under-expansion due to the heavy calcium burden.

• Brand Name: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7035120
• MDR Text Key: 92119743
• Report Number: 2134265-2017-11213
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/30/2017

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
• Device Model Number: UNK509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2017
• Initial Date FDA Received: 11/15/2017
• 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
• Treatment: 2.5X8MM RESOLUTE ONYX STENT
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR