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

Model Number	7212
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Restenosis (4576)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3 date of event was estimated based on event occurring in (b)(6) 2022.
Event or Problem Description
Agent ide study.It was reported that coronary artery disease occurred.On (b)(6) 2021, the subject presented with stable angina (ccs classification: 3) and the index procedure was performed the same day.The subject was on a prior regimen of aspirin (>= 72 hours) at the time of index procedure.A loading dose of 325 mg of aspirin and 600 mg clopidogrel were given prior to the procedure.The target lesion was located at the proximal left circumflex artery (lcx) and was 12 mm long with a reference vessel diameter of 3.00 mm.The target lesion was predilated with 3.0 mm x 12 mm balloon with 90% residual stenosis and timi flow of 3.Following pre-dilation, the lesion was treated with 3.0 mm x 12 mm nc emerge mr balloon successfully, with 30% residual stenosis and timi flow of 3.Post dilation was not performed.In (b)(6) 2022, the subject started experiencing shortness of breath, not able to exercise for prolonged time and mild chest discomfort at peak exertion and was diagnosed with coronary artery disease.On (b)(6) 2022, , the subject came to hospital with shortness of breath and hospitalized for further evaluation and treatment.At the time of the event, the subject was on aspirin and clopidogrel.Coronary angiography revealed 99% in-stent restenosis (isr) in the proximal lcx.Following predilation with a 2.5 mm x 12 mm emerge mr, a 2.5 mm x 16 mm synergy xd drug eluting stent was deployed.The lesion was then post dilated with a 2.75 mm x 8 mm nc emrge mr balloon resulting in 0% stenosis with timi flow 3.The event was considered recovered/resolved and the subject was discharged on dual antiplatelet therapy.
Additional Manufacturer Narrative
B3 date of event was estimated based on event occurring in january 2022.
Event or Problem Description
Agent ide study.It was reported that coronary artery disease occurred.On (b)(6) 2021, the subject presented with stable angina (ccs classification: the index procedure was performed the same day.The subject was on a prior regimen of aspirin (>= 72 hours) at the time of index procedure.A loading dose of 325 mg of aspirin and 600 mg clopidogrel were given prior to the procedure.The target lesion was located at the proximal left circumflex artery (lcx) and was 12 mm long with a reference vessel diameter of 3.00 mm.The target lesion was predilated with 3.0 mm x 12 mm balloon with 90% residual stenosis and timi flow of 3.Following pre-dilation, the lesion was treated with 3.0 mm x 12 mm nc emerge mr balloon successfully, with 30% residual stenosis and timi flow of 3.Post dilation was not performed.In (b)(6) 2022, the subject started experiencing shortness of breath, not able to exercise for prolonged time and mild chest discomfort at peak exertion and was diagnosed with coronary artery disease.On (b)(6) 2022, the subject came to hospital with shortness of breath and hospitalized for further evaluation and treatment.At the time of the event, the subject was on aspirin and clopidogrel.Coronary angiography revealed 99% in-stent restenosis (isr) in the proximal lcx.Following predilation with a 2.5 mm x 12 mm emerge mr, a 2.5 mm x 16 mm synergy xd drug eluting stent was deployed.The lesion was then post dilated with a 2.75 mm x 8 mm nc emrge mr balloon resulting in 0% stenosis with timi flow 3.The event was considered recovered/resolved and the subject was discharged on dual antiplatelet therapy.It was further reported that during the index procedure, following pre-dilation, the target lesion was treated with the 3.00 x 12mm study device and post dilated with a 3.25 x 12mm non-boston scientific balloon.The subject was discharged home on aspirin and clopidogrel.In (b)(6) 2022, the subject sometimes experienced chest discomfort at peak exertion.When the subject presented to the hospital in (b)(6) 2022, they had been experiencing shortness of breath for the previous six weeks.
Additional Manufacturer Narrative
B3 date of event was estimated based on event occurring in january 2022.
Event or Problem Description
Agent ide study it was reported that coronary artery disease occurred.On (b)(6) 2021, the subject presented with stable angina (ccs classification: 3) and the index procedure was performed the same day.The subject was on a prior regimen of aspirin ( 72 hours) at the time of index procedure.A loading dose of 325 mg of aspirin and 600 mg clopidogrel were given prior to the procedure.The target lesion was located at the proximal left circumflex artery (lcx) and was 12 mm long with a reference vessel diameter of 3.00 mm.The target lesion was predilated with 3.0 mm x 12 mm balloon with 90% residual stenosis and timi flow of 3.Following pre-dilation, the lesion was treated with 3.0 mm x 12 mm nc emerge mr balloon successfully, with 30% residual stenosis and timi flow of 3.Post dilation was not performed.In (b)(6) 2022, the subject started experiencing shortness of breath, not able to exercise for prolonged time and mild chest discomfort at peak exertion and was diagnosed with coronary artery disease.On (b)(6) 2022, the subject came to hospital with shortness of breath and hospitalized for further evaluation and treatment.At the time of the event, the subject was on aspirin and clopidogrel.Coronary angiography revealed 99% in-stent restenosis (isr) in the proximal lcx.Following predilation with a 2.5 mm x 12 mm emerge mr, a 2.5 mm x 16 mm synergy xd drug eluting stent was deployed.The lesion was then post dilated with a 2.75 mm x 8 mm nc emrge mr balloon resulting in 0% stenosis with timi flow 3.The event was considered recovered/resolved and the subject was discharged on dual antiplatelet therapy.It was further reported that during the index procedure, following pre-dilation, the target lesion was treated with the 3.00 x 12mm study device and post dilated with a 3.25 x 12mm non-boston scientific balloon.The subject was discharged home on aspirin and clopidogrel.In (b)(6) 2022, the subject sometimes experienced chest discomfort at peak exertion.When the subject presented to the hospital in (b)(6) 2022, they had been experiencing shortness of breath for the previous six weeks.

• Brand Name: NC EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 15228249
• Report Number: 2134265-2022-08518
• Device Sequence Number: 5634017
• Product Code: LOX
• UDI-Device Identifier: 08714729846390
• UDI-Public: 08714729846390
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/20/2023
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0027696289
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2022
• Supplement Date Received by Manufacturer: 09/16/2022; 07/14/2023
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 09/28/2022; 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Race: White