MAUDE Adverse Event Report: ASAHI INTECC SION; GUIDE WIRE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Perforation of Vessels (2135)

Event Type  Injury  

Event Description

Cardiovascular revascularization medicine 17 (2016) 412-417.Title: distal coronary perforation in patients with prior coronary artery bypass graft surgery: the importance of early treatment.[case2]: a 75-year-old man with a prior cabg and medically refractory angina was referred for pci of a proximal rca cto (fig.4a).The cto had a clear proximal cap, approximately 100 mm length, and the distal cap was very calcified and located at the bifurcation of the right posterolateral and right pda.The pda filled by septal interventional collaterals from the lad.Antegrade crossing attempts with a pilot 200 (abbott vascular) and gaia 2nd (asahi intecc) guidewire advanced through a corsair catheter failed to cross past the highly calcified distal cap.Use of contrast micro-injection (carlino technique) and multiple stiff guidewires (confianza pro 12 and gaia 3rd, asahi intecc) failed to penetrate the distal cap.Retrograde crossing was achieved with a sion guidewire (asahi intecc) through a septal collateral (fig.4c).Retrograde penetration of the distal cap was extremely challenging but was eventually successful with a knuckled retrograde pilot 200 guidewire (fig.4e).Reverse controlled antegrade and retrograde subintimal tracking was performed successfully (fig.4f) and the retrograde guidewire was externalized (fig.4g).After stent implantation antegrade flow was restored to the pda, but a distal vessel perforation was observed in a side branch of the pda (fig.4h).A balloon was inflated to stop antegrade flow followed by implantation of a 2.8 × 19mmgraftmaster rx stent (abbot vascular) through a guideliner (vascular solutions), with sealing of the perforation (fig.4i).The patient had an uneventful recovery and significant improvement in angina.

• Brand Name: SION
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 16538554
• MDR Text Key: 311249780
• Report Number: 3004718255-2023-00292
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/14/2023
• Distributor Facility Aware Date: 02/22/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Male