MAUDE Adverse Event Report: ASAHI INTECC FIELDER XT; 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.[case 1].A 71-year-old man with a history of chronic obstructive pulmonary disease and three-vessel cabg presented with worsening dyspnea on exertion and angina.Myocardial perfusion imaging revealed inferior wall ischemia.Coronary angiography revealed patent left anterior descending artery (lad) with cto of the distal circumflex and the right coronary artery (rca, fig.1a).All previously placed aortocoronary bypass grafts were occluded.The right posterior descending artery (pda) was a small, diffusely diseased vessel that filled via septal collaterals from the lad (fig.1a).A trial of medical therapy was done for 3months but the patient continued to have significant exertional dyspnea and angina, and was referred for cto pci of the rca.Bilateral femoral arterial access was obtained with 8f 45-cm long sheaths.The rca was engaged with an 8f al 1 guide catheter and the left main coronary artery with an 8f ebu 3.75 guide catheter.Dual injection revealed long occlusion length, blunt proximal cap, and severe calcification and tortuosity.The j-cto score was 4, suggesting high pci difficulty [6].The proximal rca diameter was 3.5-4.0mm, indicating that the rca was a large vessel supplying a sizable territory.Due to the small size of the pda, a primary retrograde approach was attempted through septal collaterals, but multiple attempts to cross the collaterals with a sion (asahi intecc, nagoya, japan) and fielder fc (asahi intecc) guidewires through a corsair microcatheter (asahi intecc) using both a "surfing" and contrast-guided approach were unsuccessful (fig.1b).We then attempted antegrade crossing, initially with a crossboss catheter (boston scientific, natick, massachusetts) that could not advance past the mid rca, in spite of predilatation with a 1.5 mm balloon.A knuckled fielder xt guidewire (asahi intecc) was advanced to the right posterolateral branch (fig.1c), and was then redirected into the pda (fig.1d).The fielder xt guidewire entered a branch of the pda, but a gaia 2nd guidewire (asahi intecc) was advanced using a twin pass catheter (vascular solutions, minneapolis, minnesota) to the pda (fig.1e).Using the "double-blind stick and swap" technique [7] with a stingray balloon and guidewire (boston scientific), a pilot 200 guidewire (abbott vascular, santa clara, ca) successfully entered the pda (fig.1f).After predilatation perforation of a side branch of the pda was seen.The contrast did not clear, suggesting the extravasation was contained (fig.2a).However, the area of contrast stain appeared to increase after stent implantation was performed (fig.2b).Transthoracic echocardiography did not demonstrate any effusion (fig.2c).After a few minutes, the patient developed acute st-segment elevation (fig.2d and e).Left main angiography did not demonstrate any change in left main antegrade flow (fig.2f) and transthoracic echocardiography remained unchanged.Right coronary angiography demonstrated ellis grade 3 distal perforation (fig.3a).A balloon was inflated in the mid rca to stop antegrade flow (fig.3b), and given the electrocardiographic changes the patient was emergently intubated.After implantation of 3 coils through a progreat microcatheter (terumo, somerset, nj) the perforation was sealed (fig.3c and d).Transesophageal echocardiography demonstrated a loculated effusion along the inferolateral wall of the left ventricle (fig.3e and f).No collateral flow to the perforate segment from the left anterior descending artery could be seen.The patient remained hemodynamically stable, although st-segment elevation persisted.After observation for 60min in the cardiac catheterization laboratory, he was transferred to the intensive care unit.Upon arrival to the unit he developed pulseless electrical activity and could not be resuscitated; emergent bedside echocardiography did not demonstrate a pericardial effusion, and attempts for pericardiocentesis did not help (draining catheter was likely placed in the right ventricle).The family declined autopsy.

• Brand Name: FIELDER XT
• 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: 16535005
• MDR Text Key: 311237082
• Report Number: 3004718255-2023-00290
• 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: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• 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: 03/13/2023
• 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: 71 YR
• Patient Sex: Male