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 Problems Death (1802); ST Segment Elevation (2059); Perforation of Vessels (2135)

Event Date 11/11/2019

Event Type  Death  

Event Description

It was reported that patient death occurred.A 1.75 mm rotalink plus catheter and rotawire were selected for use for a percutaneous coronary intervention (pci) procedure of the target lesion was located in the left main and mid left anterior descending artery (lad).The patient had aortic stenosis.During the procedure, intravascular ultrasound (ivus) was placed down the vessel to determined that rotablation would be appropriate to get the best result.The 1.75mm rotalink plus catheter was advanced over the rotawire and it went smoothly without complications.Based on ivus, a 2.5 diameter synergy placed mid to distal lad then placed a 3.5 diameter synergy proximal to the first stent with good expansion with both stents.The physician decided to post dilate the stents with the 3.5 stent balloon.During these inflations the patient had became a little agitated and tired of lying on the table.While post dilating the stents the patient came a little off the table, bending at the waist.The balloon was inflated during this period.The patient was able to relax and the physician noticed st elevations on the patient's electrocardiography (ekg).The physician decided to inject contrast into the vessel and noticed the coronary vessel was perforated.Quick attempts were made to try to resolve the issue.However, the patient passed away from the perforation that was unable to be properly sealed.The physician believed that the patient was very sick with a lot of calcium and unfortunately some plaque probably shifted and caused the perforation.

• Brand Name: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9383634
• MDR Text Key: 168225073
• Report Number: 2134265-2019-14538
• 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: 11/27/2019

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2019
• Initial Date FDA Received: 11/27/2019
• 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 Age: 84 YR