MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. CONFIANZA PRO 12; GUIDE WIRE

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Death (1802); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Laceration(s) (1946); Thrombus (2101); Pericardial Effusion (3271)

Event Date 08/04/2020

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2020, this was a planned percutaneous coronary intervention of both the left anterior descending (lad) coronary and ramus intermedius arteries with impella support due to severely depressed biventricular function.A non-abbott stent was implanted in the ramus.The lad was crossed and predilatation was performed with an unspecified balloon over a prowater guide wire.Shortly thereafter, abrupt hypotension occurred and a coronary perforation was suspected.A balloon was inflated to temporarily halt flow into the lad in order to stop the bleeding.Pericardiocentesis was attempted but was unsuccessful.The patient went into cardiac arrest and cardiopulmonary resuscitation was performed for 20 minutes with defibrillation and the patient was resuscitated.The angiogram showed a large thrombus burden in the left main artery.It was unclear if thrombus was the cause of acute decompensation or if it developed during prolonged resuscitative effort.Heparin and aspiration thrombectomy were performed with complete resolution of the thrombus.A dissection was made in the lad in order to cross the chronic total occluded (cto) lesion and was noted as expected without contrast extravasation or evidence of perforation.Intravascular ultrasound (ivus) was then performed and revealed possible plaque shift in the left circumflex (lcx) which was treated with a 3.0x38mm xience stent.Due to persistent hypotension requiring medication, a repeat echocardiogram was performed and revealed enlarging pericardial effusion.Pericardiocentesis was performed with removal of about 500 cc fluid.Patient's hemodynamics improved transiently but remained tenuous and the pericardial drain continued to have significant output.Both a non-abbott stent and a 4.0x19mm graftmaster covered stent were implanted in overlapping fashion in the lcx and left main to intentionally exclude the lad in order to stop the bleeding given the unclear source of blood loss.After covered stent placement to stop the flow into the lad, the pericardial drain output slowed as expected.Due to persistent pericardial drain output, heparin effect was reversed with protamine 10 mg.Afterward, the pericardial drain output slowed even further.The patient was transferred to the cardiac care unit (ccu) in tenuous, critical condition.The patient expired the next day on (b)(6) 2020 secondary to right ventricle laceration following withdrawal of care post procedure.It was noted the graftmaster did not cause the laceration.No additional information was provided.The patient died of right ventricle laceration.The cause of the rv laceration is unknown.

• Brand Name: CONFIANZA PRO 12
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 10486698
• MDR Text Key: 232523859
• Report Number: 3004718255-2020-00158
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/02/2020,08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• 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: 09/02/2020
• Distributor Facility Aware Date: 08/04/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 61