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

Model Number 3851

Device Problem Failure to Advance (2524)

Patient Problem Cardiac Arrest (1762)

Event Date 01/07/2022

Event Type  Death  

Event Description

It was reported via a journal article that patient death occurred.The 53% stenosed, 8mmx1.5mm in diameter target lesion was located in distal left anterior descending artery.An 81-year-old male patient who had unstable angina was treated.The patient had a history of percutaneous transluminal coronary angioplasty (ptca), hypertension, dyslipidemia, and diabetes.The patient had also taken aspirin (100mg/day), clopidogrel (75mg/day), and atorvastatin (10mg/day).A 10mmx2.25mm wolverine coronary cutting balloon was selected for use.The patient visited the hospital with a chief complaint of loss of consciousness.Implantable cardiac monitor (icm) was implanted in patient chest.Elective percutaneous coronary intervention was performed to treat unstable angina.A non-bsc guidewire was inserted in the distal left anterior descending artery.Ivus catheter was inserted to observe the lesion.The lesion was tried to dilate using the 10mmx2.25mm wolverine coronary cutting balloon, but it was unable to cross the lesion.The lesion was pre-dilated using a non-bsc balloon catheter and lesion was dilated successfully.A non-bsc coronary stent was placed in the lesion, and when the ivus catheter was inserted inside the stent, yet resistance was felt.The observation inside the vessel was still performed, and apposition failure of this stent was confirmed.Post dilation was performed in the placement site of the stent using the non-bsc balloon catheter.Stent placement condition was observed using the ivus catheter, and good apposition of this stent was confirmed.The procedure was completed using this device.On (b)(6) 2022, the patient was discharged without any problem.However, on (b)(6) 2022, the patient died at home due to cardiac death of unknown cause.Icm analysis was performed and confirmed that death was not due to arrhythmia.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON MONORAIL
• 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: 15878475
• MDR Text Key: 304443640
• Report Number: 2124215-2022-49621
• 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: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2022
• 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): Death
• Patient Age: 81 YR
• Patient Sex: Male