MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

Model Number 3854

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 06/17/2022

Event Type  Injury  

Event Description

Agent ide study.It was reported that thrombus occurred.The subject presented emergently with the complaints of chest pain and shortness of breath and was hospitalized for further treatment and evaluation.A physical examination revealed chest pain, dyspnea on exertion, orthopnea and paroxysmal nocturnal dyspnea, shortness of breath and muscle cramps.At the time of the event, the subject was on aspirin and ticagrelor.Diagnostic catheterization, ivus and optical coherence tomography were performed as the diagnostics for the event.The subject was diagnosed with ccs ii typical angina.The 90% restenosis in the proximal circumflex (lcx) was treated using a 12 x 2.50 mm mm emerge monorail balloon, followed by treatment with 10 x 3.50 mm wolverine monorail cutting balloon and 15 x 4.00 mm nc non boston scientific (bsc) balloon.Following this, a 15 x 4.00 mm nc non bsc balloon was inflated and the target lesion was treated with a 20 x 4.00 mm agent dcb study device.Post revascularization 30% residual stenosis was noted with timi flow 3.Optical coherence tomography (oct) was performed, which showed thrombus/neointimal flap associated with the ostial lcx stent but protruding into the distal left main coronary artery (lmca).Ballooning from the lmca to left anterior descending artery (lad) did not resolve the thrombus.A 0.9 mm x 135 mm non bsc ultraviolet laser was used on the lcx and lad.A 10 x 3.50 mm wolverine monorail cutting balloon and a 15 x 4.00 mm nc non-bsc balloon were inflated at the proximal lad.Ivus was performed and an 8 x 5.00 mm nc quantum apex mr balloon was inflated in the lad.The event was also treated medically.The next day, the event was considered to be recovered/resolved and the subject was discharged on the same day to home on eliquis and ticagrelor.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15420444
• MDR Text Key: 299888183
• Report Number: 2124215-2022-35290
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/14/2022

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
• Device Operator: Health Professional
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2022
• Initial Date FDA Received: 09/14/2022
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male