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

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

Patient Problem Perforation of Vessels (2135)

Event Date 08/01/2023

Event Type  Injury  

Event Description

It was reported that a perforation occurred requiring additional intervention.The patient presented with a subacute anterior myocardial infarction.Coronary angiogram revealed 50% stenosis with severe calcification of the left main coronary artery (lmt) and 90% stenosis with severe calcification of the left anterior descending artery (lad).The target lesion, located in the lad, was debulked using rotational atherectomy as intravascular ultrasound (ivus) was unable to be performed.A 1.50mm burr was selected, followed by additional debulking with a 1.75mm burr.Pre-dilation of the lesion was completed using a 2.50 mm wolverine cutting balloon.Balloon indentation disappeared and a contrast leakage was then observed from the proximal lad.In an attempt to establish homeostasis, a 2.50 mm non-scientific balloon was introduced with multiple extended inflations, but homeostasis was unable to be achieved.A 2.50 x 10 mm non-boston scientific stent was then deployed in the lad, but bleeding continued.Ivus showed a disruption in the vessel wall due to a crack in the calcification of the distal lmt, evidencing a hemorrhage from the same area via the adventitia.A 3.00 x 15 mm non-boston scientific stent was deployed in the lmt to lad, but homeostasis was not achieved.Finally, a 3.00 x 20 mm non-boston scientific covered stent was deployed over the previous stent, occluding the left circumflex.Homeostasis was successfully achieved after difficulty locating the perforation site.

Manufacturer Narrative

B3 date of event was estimated based on aware date as no event date was provided."mp29-8_a case of lmt perforation with difficult hemostatic site identification and hemostasis," was on a poster presentation at a conference held on friday, august 4, 2023 in fukuoka, japan.

• 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; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17705481
• MDR Text Key: 322924778
• Report Number: 2124215-2023-48850
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/07/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/07/2023
• 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
• Treatment: 2.5MM RYUSEI BALLOON; 2.5MM/10MM PK PAPYRUS; 3.0MM/15MM XIENCE SKYPOINT; 3.0MM/20MM PK PAPYRUS
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female