MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. FIELDER XT; PTCA GUIDE WIRE

Device Problem Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Vascular Dissection (3160)

Event Type  Injury  

Manufacturer Narrative

Manufacturing site: manufacturing site could not be identified because the product lot number information was not available.Device evaluation could not be performed because the affected device was not returned.Lot history records review could not be conducted because lot information was unavailable.All the shipped products were inspected in the production process and satisfied the product specifications and release criteria; therefore, it was concluded that there was no anomaly in product quality.Multiple asahi products were used in the procedure; however, how each mentioned product had caused or contributed to vessel dissection was unable to be determined based on the limited written information.Referring to known similar events, it was presumed that patient anatomy and procedural contents were most likely associated with this event.Instructions for use (ifu) states: [warnings] observe movement of this guide wire in the vessels.Before this guide wire is moved or torqued, the tip movement should be examined and monitored under fluoroscopy.Do not move or torque the guide wire without observing corresponding movement of the tip; otherwise, the guide wire may be damaged and/or trauma may occur.In addition, ensure that the distal tip of this guide wire and its location in the vessel are visible during manipulations of the guide wire.Never push, auger, withdraw, or torque this guide wire that meets resistance.Torquing or pushing this guide wire against resistance may cause damage and/or tip separation of this guide wire or direct damage to a vessel.Resistance may be felt and/or observed under fluoroscopy by noting any buckling of the guide wire.If the prolapse of the guide wire tip is observed, do not allow the tip to remain in a prolapsed position; otherwise damage to the guide wire may occur.Determine the cause of resistance under fluoroscopy and take any necessary remedial action.If resistance is felt due to spasm, bending of the guide wire, or due to trap while operating this guide wire in the blood vessel or removing it, do not torque and/or pull the guide wire itself.Stop the procedure.Determine the cause of resistance under fluoroscopy and take appropriate remedial action.If the guide wire is moved excessively, it may break or become damaged, which may cause blood vessel injury or result in fragments being left inside the vessel.Use this guide wire carefully as the guide wire may penetrate the blood vessel.Otherwise, it may cause adverse events such as blood vessel perforation and coronary artery dissection.The higher torque performance, stiffer distal end, and/or higher advancement force may present a higher risk of perforation or injury than if using a more flexible guide wire.Therefore, use the most flexible guide wire that will treat the lesion (i.E., the guide wire with the smallest tip load that will treat the lesion), and take due care to minimize the risk of perforation or other damage to blood vessels.[malfunctions and adverse effects] vessel dissection.

Event Description

It was reported through a research article titled what is the cause of hypotension? a rare complication of percutaneous coronary intervention of a chronic total occlusion: a case report (european heart journal - case reports (2019) 3, 1-5) that identified asahi products: corsair, fielder xt, gaia second, and sion blue may be related to vessel dissection.Excerpt is as follows: a (b)(6) year-old lady presented with a history of treated hypertension and long-standing stable angina despite therapy with three antianginals uptitrated to maximum tolerated doses (bisoprolol 5mg o.D., amlodipine 5mg o.D., and isosorbide mononitrate 40 mg b.I.D.).Her electrocardiogram (ecg) showed sinus rhythm and no q waves.Her transthoracic echocardiogram showed preserved left ventricular systolic function with mild hypokinesia of the inferior wall and no significant valvular disease.Her coronary angiogram showed a dominant right coronary artery (rca) with cto in proximal segment, mild/moderate narrowing in proximal left anterior descending and moderate eccentric narrowing in proximal non-dominant left circumflex artery providing cross-filling to the occluded rca through epicardial collaterals.J-cto score was 1.The left coronary lesions were thought unlikely to be flow limiting and after discussion with the patient, the interventional plan was to attempt a pci to the occluded rca with antegrade wire escalation strategy.The procedure was carried out using dual access (right radial 6 fr and right femoral 8 fr).A voda left 3.5 6 fr was used to engage the left coronary system and a judkins right 4 8 fr to engage the rca.A soft, polymer-jacketed, tapered wire (fielder xt) with a microcatheter (corsair) back-up was unable to cross the occlusion.Therefore, it was switched to a stiffer polymer-jacketed wire (gaia second) which was able to cross the occlusion.The correct position in the distal true lumen was confirmed by contralateral injection.The wire was then exchanged out over the corsair to a standard coronary wire (sion blue) and balloon angioplasty was performed with a 2.5x15mm balloon in the proximal and mid-segment of rca, with subsequent evidence of extensive dissection of the vessel.Two overlapping drugeluting stents (des) (3.5x36mm and 3.5x33mm) were deployed in proximal-mid vessel, following which the patient developed hypotension (60/40mmhg).There was evidence of residual dissection in distal rca and two further overlapping des (2.5x19mm and 2.5x29mm) were deployed.The patient remained hypotensive, refractory to fluid resuscitation and intravenous phenylephrine boluses, complaining of dizziness and with evidence of raised venous pressures.A pericardial tamponade was suspected and an urgent echocardiogram was performed.This showed no pericardial effusion in subcostal view.A careful review of the coronary angiogram did not show any obvious perforations in the rca or catheter-related dissection in the left coronary system.In addition, no significant st changes were noted on ecg during the procedure.A femoral angiogram ruled out any bleeding at the access site.As the hypotension persisted, an intra-aortic balloon pump (iabp) was inserted with an augmented systolic blood pressure of 100mmhg.Urgent blood tests showed a drop in haemoglobin as compared to pre-procedure (from 13.2 to 11 g/dl).To rule out a retroperitoneal bleed, an urgent computerized tomography (ct) scan was performed.This did not show any bleeding at the femoral site but revealed a large (36x31mm) intramural haematoma (imh) in the right atrioventricular groove compressing the tricuspid valve annulus and restricting right ventricular filling.The final diagnosis was thus pseudotamponade (or dry tamponade).As the patient did not show any sign of further haemodynamic deterioration in the next few hours, a conservative management plan was adopted.After 3 days, she became normotensive (120/70mmhg) and the iabp was removed.A cardiac magnetic resonance imaging (mri) showed a localized imh, slightly smaller (28x23mm) than that seen on the ct scan.She was successfully discharged once clinically and haemodynamically stable (on day 10) with a plan to take aspirin and clopidogrel for 6months.After 7months, repeat cardiac mri showed an improvement of the haematoma which had not fully resolved but was significantly reduced in size.The patient was normotensive and free from exertional angina.

• Brand Name: FIELDER XT
• Type of Device: PTCA GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• Manufacturer (Section G): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• Manufacturer Contact: yukako homma ; 3-100 akatsuki-cho; seto, aichi 489-0-071 ; JA 489-0071
• MDR Report Key: 11256816
• MDR Text Key: 233739381
• Report Number: 3003775027-2021-00023
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K171933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2021
• 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
• Date Manufacturer Received: 01/12/2021
• 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): Required Intervention
• Patient Age: 75 YR