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

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

Patient Problems Death (1802); Perforation (2001)

Event Date 10/25/2018

Event Type  Death  

Manufacturer Narrative

Date of death: (b)(6) or (b)(6) 2018.

Event Description

It was reported that the patient experienced a vessel perforation and died.A 1.5mm rotalink burr, rotawire elite and wireclip torquer, synergy stent, and a 2.5mm emerge balloon were selected for a patient procedure.The cto was crossed with a non-bsc wire and a non-bsc catheter, and the medical personnel were unable to cross with anything else.Rotablation was performed with a 1.5 mm rotalink burr.The lesion was dilated with a 2.5mm emerge balloon and thereafter treated with a synergy drug-eluting stent of unknown size.Upon imaging performed post treatment, a perforation was noticed distal to the stent.A non-bsc stent graft system was attempted to be placed, but it was unable to cross to the area of need.An unspecified 2.5mm balloon was then used to tamponade the perforation, at which point the patient also coded.Multiple shocks were administered to the patient and the patient was revived.An non-bsc heart pump was then placed in the patient.Pericardiocentesis was performed and 1200cc of fluid was returned.The patient was taken to the cardiovascular intensive care unit in critical condition.After this, the patient was made a dnr ("do not resuscitate").The patient then died on (b)(6) 2018 or (b)(6) 2018.

• Brand Name: 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8080904
• MDR Text Key: 127455974
• Report Number: 2134265-2018-62936
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113220
• 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: 11/16/2018

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: 10/26/2018
• Initial Date FDA Received: 11/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 2.8MM GRAFTMASTER STENT GRAFT; IMPELLA HEART PUMP; PILOT 200 WIRE; TURNPIKE LP CATHETER
• Patient Outcome(s): Death; Required Intervention