MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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

Patient Problems Bradycardia (1751); Death (1802); Perforation of Vessels (2135)

Event Date 02/05/2019

Event Type  Death  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that a perforation and death occurred.A percutaneous coronary intervention was being performed on a 100% stenosed and a severely calcified lesion in the left anterior descending (lad) artery.The intervention started with an unsuccessful attempt to recanalize the lad, using 2 non-bsc guidewires and a non-bsc guide catheter.Because of the unsuccessful attempt the physician changed to the vein graft, which was connected to the distal right coronary artery which had collaterals to the medial lad.Two non-bsc guidewires were used the with septal surfing to get retrograde into the chronic total occlusion (cto) of the lad.Once they reached the cto they exchanged guidewires to cross the lesion from behind.When they crossed the lesion, the wire was subintimal and they tried with reversed cart technique to get into the lumen again.Meanwhile they inserted another non-bsc guide extension catheter and wanted to catch the wire from retrograde inside of the guide extension catheter.After a couple of attempts and with the help of ivus they finally got the subintimal wire into the normal lumen and inserted it into the non-bsc guide catheter where they trapped it with a balloon and pushed the guide catheter from retrograde.Afterwards they exchanged for a non-bsc guide wire and dilated the cto area with a nc emerge balloon from the left main bifurcation to the septal, which hosted the retrograde wire.The ostium of the lad was dilated one last time with the nc emerge balloon and at that time a perforation was noted.The balloon was immediately inflated to stop the bleeding.The patient developed bradycardia and fluid accumulation into the pericardium.A pericardiocentesis was performed and the patient was attempted to be reanimated and medication was given.While stabilizing the patient they also inserted a non-bsc heart pump.When the patient was stable, four non-bsc stents were implanted to close the perforation and covered the cto.At the end the patient was stable and had no more fluid going into the pericardium.The hear pump was removed because the pumping of the heart was satisfactory.The patient was sent to "its" for close observation.A couple days post-procedure, the patient died.

• Brand Name: NC EMERGE
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; maple grove MN
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8407933
• MDR Text Key: 138382169
• Report Number: 2134265-2019-01895
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• 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
• Date Manufacturer Received: 02/11/2019
• 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
• Treatment: 4 BIOTRONIK PAPYRUS STENTS; ABIOMED IMPELLA HEART PUMP; ASAHI CONFIANZA PRO 12 GUIDEWIRE; ASAHI CORSAIR PRO GUIDE CATHETER; ASAHI FIELDER XT-R GUIDEWIRE; ASAHI SION BLACK GUIDEWIRE; TELEFLEX GUIDELINER GUIDE EXTENSION CATHETER
• Patient Outcome(s): Death