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

Device Problem Material Rupture (1546)

Patient Problem Vascular Dissection (3160)

Event Date 05/22/2023

Event Type  Injury  

Event Description

Agent ide study.It was reported that the balloon ruptured and dissection occurred.On (b)(6) 2023, the subjected presented with worsening chest pain and was hospitalized on the same day for further evaluation and treatment.At the time of the event the subject was on aspirin and ticagrelor which was continued.Ekg revealed left branch bundle with sinus rhythm, occasional premature ventricular complexes which is similar as baseline.Chest x-ray revealed no acute cardiopulmonary disease and troponin t was elevated to 19 ng/l.Diagnostic coronary angiography revealed 80-90% in-stent restenosis from prox to mid segment for taxus stent and synergy stent.The following day, the subject was discharged on aspirin and ticagrelor.On (b)(6) 2023, ivus demonstrated stent expansion issues through the mid lad for which laser atherectomy was performed which improved the angiographic appearance.This was followed by using post dilation cutting and scoring balloons.However, the prior stent present at the proximal lad was under-expanded and did not expand with use of a wolverine cutting balloon and scoring balloon.Intravascular lithotripsy was performed, and the wolverine balloon was able to be expanded fully.The same wolverine cutting balloon was reused again and inflated to 30 atmospheres at proximal lad and the device ruptured from proximal lad into left circumflex (lcx) artery and dissected into the left main (lm) artery.This was treated by rewiring the lcx and lad artery and stenting it with 4.0 mm x 24 mm synergy megatron stent successfully.A severe lesion was noticed within lcx for which the kissing balloon technique was performed with 3.00 mm and 3.50 mm balloons at lad bifurcation and was followed by placement of 3.5mm x 12 mm synergy stent at lcx.Post dilation was performed followed by ivus revealing improved angiographic appearance.Post revascularization, the residual stenosis was 0% and timi flow is 3.Angina is ongoing, but dissection was resolved.

Event Description

Agent ide study.It was reported that the balloon ruptured and dissection occurred.On (b)(6) 2023 the subjected presented with worsening chest pain and was hospitalized on the same day for further evaluation and treatment.At the time of the event the subject was on aspirin and ticagrelor which was continued.Ekg revealed left branch bundle with sinus rhythm, occasional premature ventricular complexes which is similar as baseline.Chest x-ray revealed no acute cardiopulmonary disease and troponin t was elevated to 19 ng/l.Diagnostic coronary angiography revealed 80-90% in-stent restenosis from prox to mid segment for taxus stent and synergy stent.The following day, the subject was discharged on aspirin and ticagrelor.On (b)(6) 2023 ivus demonstrated stent expansion issues through the mid lad for which laser atherectomy was performed which improved the angiographic appearance.This was followed by using post dilation cutting and scoring balloons.However, the prior stent present at the proximal lad was under-expanded and did not expand with use of a wolverine cutting balloon and scoring balloon.Intravascular lithotripsy was performed, and the wolverine balloon was able to be expanded fully.The same wolverine cutting balloon was reused again and inflated to 30 atmospheres at proximal lad and the device ruptured from proximal lad into left circumflex (lcx) artery and dissected into the left main (lm) artery.This was treated by rewiring the lcx and lad artery and stenting it with 4.0 mm x 24 mm synergy megatron stent successfully.A severe lesion was noticed within lcx for which the kissing balloon technique was performed with 3.00 mm and 3.50 mm balloons at lad bifurcation and was followed by placement of 3.5mm x 12 mm synergy stent at lcx.Post dilation was performed followed by ivus revealing improved angiographic appearance.Post revascularization, the residual stenosis was 0% and timi flow is 3.Angina is ongoing, but dissection was resolved.It was further reported that angina was considered to be resolved 26 jun 2023.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17144387
• MDR Text Key: 317447020
• Report Number: 2124215-2023-31186
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 07/17/2023

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2023
• Initial Date FDA Received: 06/16/2023
• Supplement Dates Manufacturer Received: 06/27/2023
• Supplement Dates FDA Received: 07/17/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Race: White