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

Model Number	7132
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Reduced Blood Flow (4598)
Date of Event	07/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Agent ide: it was reported that decreased blood flow occurred.In (b)(6) 2022, the subject presented with stable angina.Heparin or other antithrombotic medications were administered at the time of the index procedure.A loading dose of 324 mg of aspirin was given prior to the procedure.The target lesion was located at the proximal left circumflex artery (lcx) and was 6 mm long with a reference vessel diameter of 4.0 mm.The target lesion was predilated using a 4.0 mm x 8 mm balloon and a cutting balloon with 90% residual stenosis and timi flow of 3.Following pre-dilation, the lesion was treated with 4.0 mm x 12 mm emerge balloon.Final angiographic results revealed 20% residual stenosis and timi flow of 3.Post treatment decreased blood flow was noted at the ostial diagonal branch.The event was treated with additional intervention using plain old balloon angioplasty to successfully restore blood flow.The event was considered recovered/ resolved and the subject was discharged on the same day on aspirin and clopidogrel.
Event or Problem Description
Agent ide it was reported that decreased blood flow occurred.In (b)(6) 2022, the subject presented with stable angina.Heparin or other antithrombotic medications were administered at the time of the index procedure.A loading dose of 324 mg of aspirin was given prior to the procedure.The target lesion was located at the proximal left circumflex artery (lcx) and was 6 mm long with a reference vessel diameter of 4.0 mm.The target lesion was predilated using a 4.0 mm x 8 mm balloon and a cutting balloon with 90% residual stenosis and timi flow of 3.Following pre-dilation, the lesion was treated with 4.0 mm x 12 mm emerge balloon.Final angiographic results revealed 20% residual stenosis and timi flow of 3.Post treatment decreased blood flow was noted at the ostial diagonal branch.The event was treated with additional intervention using plain old balloon angioplasty to successfully restore blood flow.The event was considered recovered/ resolved and the subject was discharged on the same day on aspirin and clopidogrel.It was further reported that there was an ostial compromise of a very proximal d1 branch from plaque shift after lcx percutaneous coronary intervention (pci).

• Brand Name: EMERGE
• Common Device Name: 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15755580
• Report Number: 2124215-2022-44726
• Device Sequence Number: 6364208
• Product Code: LOX
• UDI-Device Identifier: 08714729806165
• UDI-Public: 08714729806165
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K113220
• 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
• Report Date (Section B): 11/30/2022

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: 02/17/2024
• Device Model Number: 7132
• Device Catalogue Number: 7132
• Device Lot Number: 0027535179
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/25/2022
• Supplement Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2021
• 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: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Race: White