MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. GAIA SECOND; PTCA GUIDE WIRE

Device Problem Insufficient Information (3190)

Patient Problems Hematoma (1884); Vascular Dissection (3160)

Event Type  Injury  

Manufacturer Narrative

Manufacturing site was unable to be identified because lot information was unavailable.Device evaluation could not be performed because the affected device was not returned.Lot history records review could not be conducted because of unavailability of lot information.All the shipped products were inspected in the production process and satisfied the product specifications ad release criteria; therefore, it was concluded that there was no anomaly in product quality.Multiple asahi and non-asahi products were used in the procedure; however, which product had cause or contributed to the septal hematoma 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.[malfunction and adverse effects] damage to a vessel, including possible vessel perforation, vessel dissection.

Event Description

It was reported through a research article titled "a case report of right ventricular compression from a septal haematoma during retrograde coronary intervention to a chronic total occlusion (european heart journal (2019) 3, 1-4 case report doi:10.1093/ehjcr/ytz089)" that identified asahi products: sion and gaia second may be related to vessel damage that developed to a hematoma.Excerpt is as follows: a (b)(6) year-old woman with hypertension and hyperlipidaemia developed typical angina with an inability to carry any physical activity ((b)(6) cardiovascular society class iv) over a 6-month timeframe.The patient then underwent coronary angiography, which showed a right coronary artery (rca) cto with no other significant epicardial coronary artery disease.Due to her ongoing symptoms and single vessel disease, the decision was made to proceed with cto pci.Due to patient preference to immediately ambulate post-procedure, a biradial approach was chosen for her cto pci.The patient was pre-loaded with aspirin and clopidogrel, and underwent cto pci with a 7-fr al 0.75 guide and a 7-fr ebu 3.5 guide.Dual angiography revealed a mid-rca cto, which was approximately 24 mm in length.The plan was made to proceed with an antegrade approach using heparin with a target activated clotting time (act) of >300 s.An antegrade approach was initially attempted utilizing a turnpike microcatheter and the following guidewires in serial succession: fielder xt-a, pilot 200, and gaia 2nd.However, these wires kept going subintimal and there was also a wire exit with the gaia 2nd wire.The cto strategy was then switched to a retrograde approach utilizing a turnpike 150 cm microcatheter.The act target was now increased to >350 s.A septal collateral to the right posterior descending artery was crossed with the use of a sion wire.A gaia 2nd wire was then used retrograde to successfully cross the cto from the distal true lumen to the proximal true lumen, which was then exchanged for a r350 externalizable wire.Percutaneous coronary intervention was then performed on the externalized wire via standard fashion with an excellent angiographic result.She fared well without any haemodynamic stability or arrhythmias initially in the post-procedural area.A conservative management strategy was initially chosen, where she was observed on the cath lab table for approximately 2 h.No additional fluid or anticoagulation was given.Reversal of her anticoagulation was not performed because her act fell to sub-therapeutic levels quickly post-procedure.She fared well without any haemodynamic stability or arrhythmias initially in the post-procedural area.However, the patient developed a sudden onset 8 of 10 chest pain.The heart rate at the time was 94 b.P.M., blood pressure of 100/ 60mmhg, and 98% oxygen saturation on room air.Her electrocardiogram demonstrated only sinus tachycardia.However, she was brought back to the cath lab due to her ongoing pain where a repeat angiogram demonstrated expansion of the septal haematoma.Due to the enlarging size of the haematoma, she underwent coiling of the inflow and outflow of the culprit septal collateral (of note, the patient did receive heparin for the coiling procedure, to prevent clotting of the required catheters and devices.).The patient was then transferred to the cardiac care unit.While initially stable post-procedure, the patient became hypotensive to 70/48mmhg and failed to improve with over 3 l of fluid resuscitation and inotropes (dopamine and norepinephrine) over the next two hours.A transthoracic echocardiogram demonstrated almost complete obliteration of the entire right ventricle (rv) from the haematoma, but with normal left ventricular function.The septal haematoma measured 4.2 cm in certain views, and a trivial pericardial effusion was noted.Due to severe right-sided failure, the patient underwent placement of a percutaneous rv assist device, impella rp (abiomed, danvers, ma, usa) via a right femoral approach.The impella was placed at p-9, which was the maximal performance level of the device.Her haemodynamics normalized immediately and over the next few days, the septal haematoma steadily decreased in size.The impella rp was weaned steadily to p2 and removed.During the process, the patient was maintained on dual-antiplatelet therapy with aspirin and clopidogrel.The patient was discharged after a baseline cardiac magnetic resonance imaging (mri) was performed.A follow-up mri scan 3 months post-procedure demonstrated resolution of the haematoma.The patient was seen 4 months post-procedure in follow-up clinic and found to be symptom free with no limitations.

• Brand Name: GAIA SECOND
• 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: 11256809
• MDR Text Key: 233738371
• Report Number: 3003775027-2021-00020
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 63 YR