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

Model Number 7313

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

Patient Problems Bradycardia (1751); Ischemia (1942); Myocardial Infarction (1969); Pulmonary Edema (2020); Tachycardia (2095)

Event Date 11/11/2021

Event Type  Death  

Event Description

It was reported that patient death occurred.A live broadcast of a high risk percutaneous coronary intervention, with a culotte technique approach, was performed on a bifurcated lesion located in the left main, left circumflex, and ostial marginal artery.The patient was noted to have presented to the case in poor condition, with a history of diabetes.035/180/3mm amplatz guidewire, 2.00mm x 15mm emerge balloon, two 2.50mm x 15mm emerge balloons, 4.00mm x 12mm emerge balloon, 2.25mm x 12mm emerge balloon, 4.00mm x 6mm emerge balloon, 2.25 x 16 synergy stent, 3.00 x 16 synergy stent, 2.25 x 28 synergy stent, 2.00 mm x 20.00 mm agent dcb, and opticross hd vascular imaging were used to treat the patient.It was noted that the stents were deployed and no issues with any of the devices occurred.Following treatment with the devices, the patients condition descending rapidly due to the intervention, but was noted to not be considered device related.The patient went into pulmonary edema, was intubated, and then ultimately passed away.

Event Description

It was reported that patient death occurred.A live broadcast of a high risk percutaneous coronary intervention, with a culotte technique approach, was performed on a bifurcated lesion located in the left main, left circumflex, and ostial marginal artery.The patient was noted to have presented to the case in poor condition, with a history of diabetes.035/180/3mm amplatz guidewire, 2.00mm x 15mm emerge balloon, two 2.50mm x 15mm emerge balloons, 4.00mm x 12mm emerge balloon, 2.25mm x 12mm emerge balloon, 4.00mm x 6mm emerge balloon, 2.25 x 16 synergy stent, 3.00 x 16 synergy stent, 2.25 x 28 synergy stent, 2.00 mm x 20.00 mm agent dcb, and opticross hd vascular imaging were used to treat the patient.It was noted that the stents were deployed and no issues with any of the devices occurred.Following treatment with the devices, the patient's condition descending rapidly due to the intervention, but was noted to not be considered device related.The patient went into pulmonary edema, was intubated, and then ultimately passed away.It was further reported that the patient presented with ischemia.A left femoral approach was used on the target lesion.The circumflex and intermediate arteries was wired with another manufacturers guidewire and the opticross used in the intermediate ramus.It was very small vessel 2mm in caliber graft anastomosis.The left main and ostial marginal bifurcation showed extensive disease with calcium.The left main arteries true size was 4mm proximally.The lesion was thrombotic prior to stent deployment.The 2.25 x 16 synergy was implanted into the ramus and post dilated with a 2.50mm x 15mm balloon.The distal run off looked good.Intravascular ultrasound ivus was re-performed, showing good stent placement.Atrioventricular circumflex artery was wired with another manufactures guidewire and a 1.5x12mm balloon was used to pre-dilate the atrioventricular circumflex.It was noted that the sat scholastic aptitude test was low.The patient experienced pulmonary edema due to reduced flow down the left anterior descending lad artery.Then, the patient was intubated.Atrioventricular circumflex wired with another manufacturers guidewire and a 2.00 mm x 20 mm agent balloon was inflated to nominal pressure for 10 secs.Low pressure was observed as intubated with bradycardia.A 3.00 x 16 synergy drug eluting stent was deployed in the left main.Chest compressions were performed, adrenaline and atropine were given to the patient.Tachycardia was observed with loss of side branch.A 4.00mm x 6mm emerge balloon was used in mid and ostial left main stem lms.A temporary cardiac pacing wire was inserted along with another manufactures catheter to rewire into the jailed branch, another manufacturers balloon passed behind stent in attempt to open side branch flow.A 2.25mm x 12mm emerge balloon was used to anchor, however there was no output reported.Chest compression were restarted and chest compression system was applied.A heart pump was deployed but there was no output.Patient declared deceased.It was noted that in the physician's opinion the patient complication was not related to the devices.The documented cause of death was myocardial infarction.

Manufacturer Narrative

B5: describe event or problem: updated.B7: other relevant history: updated.

Event Description

It was reported that patient death occurred.A live broadcast of a high risk percutaneous coronary intervention, with a culotte technique approach, was performed on a bifurcated lesion located in the left main, left circumflex, and ostial marginal artery.The patient was noted to have presented to the case in poor condition, with a history of diabetes.035/180/3mm amplatz guidewire, 2.00mm x 15mm emerge balloon, two 2.50mm x 15mm emerge balloons, 4.00mm x 12mm emerge balloon, 2.25mm x 12mm emerge balloon, 4.00mm x 6mm emerge balloon, 2.25 x 16 synergy stent, 3.00 x 16 synergy stent, 2.25 x 28 synergy stent, 2.00 mm x 20.00 mm agent dcb, and opticross hd vascular imaging were used to treat the patient.It was noted that the stents were deployed and no issues with any of the devices occurred.Following treatment with the devices, the patient's condition descending rapidly due to the intervention, but was noted to not be considered device related.The patient went into pulmonary edema, was intubated, and then ultimately passed away.It was further reported that the patient presented with ischemia.A left femoral approach was used on the target lesion.The circumflex and intermediate arteries was wired with another manufacturers guidewire and the opticross used in the intermediate ramus.It was very small vessel 2mm in caliber graft anastomosis.The left main and ostial marginal bifurcation showed extensive disease with calcium.The left main arteries true size was 4mm proximally.The lesion was thrombotic prior to stent deployment.The 2.25 x 16 synergy was implanted into the ramus and post dilated with a 2.50mm x 15mm balloon.The distal run off looked good.Intravascular ultrasound ivus was re-performed, showing good stent placement.Atrioventricular circumflex artery was wired with another manufactures guidewire and a 1.5x12mm balloon was used to pre-dilate the atrioventricular circumflex.It was noted that the sats (oxygen saturation) was low.The patient experienced pulmonary edema due to reduced flow down the left anterior descending lad artery.Then, the patient was intubated.Atrioventricular circumflex wired with another manufacturers guidewire and a 2.00 mm x 20 mm agent balloon was inflated to nominal pressure for 10 secs.Low pressure was observed as intubated with bradycardia.A 3.00 x 16 synergy drug eluting stent was deployed in the left main.Chest compressions were performed, adrenaline and atropine were given to the patient.Tachycardia was observed with loss of side branch.A 4.00mm x 6mm emerge balloon was used in mid and ostial left main stem lms.A temporary cardiac pacing wire was inserted along with another manufactures catheter to rewire into the jailed branch, another manufacturers balloon passed behind stent in attempt to open side branch flow.A 2.25mm x 12mm emerge balloon was used to anchor, however there was no output reported.Chest compression were restarted and chest compression system was applied.A heart pump was deployed but there was no output.Patient declared deceased.It was noted that in the physician's opinion the patient complication was not related to the devices.The documented cause of death was myocardial infarction.It was further reported that following deployment of the second referenced 3.00 mm x 16 mm synergy stent in the left main artery, a third 2.25 mm x 16 mm synergy stent was placed in an unknown location.

• 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12924918
• MDR Text Key: 281674779
• Report Number: 2134265-2021-15298
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2023
• Device Model Number: 7313
• Device Catalogue Number: 7313
• Device Lot Number: 0027858758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2021
• 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: 035/180/3MM AMPLATZ GUIDEWIRE-BSC; 035/180/3MM AMPLATZ GUIDEWIRE-BSC; 035/180/3MM AMPLATZ GUIDEWIRE-BSC; 1.0MM SAPPHIRE BALLOON CARDIOVASCULAR SYSTEM INC; 1.0MM SAPPHIRE BALLOON CARDIOVASCULAR SYSTEM INC; 2.00 MM X 20.00MM AGENT DCB MR-BSC; 2.00 MM X 20.00MM AGENT DCB MR-BSC; 2.00 MM X 20.00MM AGENT DCB MR-BSC; 2.00MM X 15MM EMERGE BALLOON-BSC; 2.00MM X 15MM EMERGE BALLOON-BSC; 2.00MM X 15MM EMERGE BALLOON-BSC; 2.25 X 16 SYNERGY STENT-BSC; 2.25 X 16 SYNERGY STENT-BSC; 2.25 X 16 SYNERGY STENT-BSC; 2.25 X 28 SYNERGY STENT-BSC; 2.25 X 28 SYNERGY STENT-BSC; 2.25 X 28 SYNERGY STENT-BSC; 2.25MM X 12MM NC EMERGE BALLOON-BSC; 2.25MM X 12MM NC EMERGE BALLOON-BSC; 2.25MM X 12MM NC EMERGE BALLOON-BSC; 2.50MM X 15MM NC EMERGE BALLOON-BSC; 2.50MM X 15MM NC EMERGE BALLOON-BSC; 2.50MM X 15MM NC EMERGE BALLOON-BSC; 3.00 X 16 SYNERGY STENT-BSC; 3.00 X 16 SYNERGY STENT-BSC; 3.00 X 16 SYNERGY STENT-BSC; 4.00MM X 12MM NC EMERGE BALLOON-BSC; 4.00MM X 12MM NC EMERGE BALLOON-BSC; 4.00MM X 12MM NC EMERGE BALLOON-BSC; 4.00MM X 6MM NC EMERGE BALLOON-BSC; 4.00MM X 6MM NC EMERGE BALLOON-BSC; 4.00MM X 6MM NC EMERGE BALLOON-BSC; OPTICROSS HD-BSC; OPTICROSS HD-BSC; OPTICROSS HD-BSC; SASUKE DUAL LUMEN CATHETER ASAHI; SASUKE DUAL LUMEN CATHETER ASAHI; SION BLUE WIRE ASAHI; SION BLUE WIRE ASAHI
• Patient Outcome(s): Death
• Patient Sex: Female