MAUDE Adverse Event Report: WILLIAM COOK EUROPE UNKNOWN; DQX WIRE, GUIDE, CATHETER

Catalog Number UNKNOWN

Device Problem Malposition of Device (2616)

Patient Problems Hematoma (1884); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Journal article "higuchi et al: pulmonary hemorrhaging caused by acute severe mitral regurgitation during transcatheter aortic valve implantation".Catalog #: unknown but referred to as lunderquist extra-stiff wire guide.Name and address for importer site: (b)(4).Similar to device under 510(k): k061670.Investigation is still in progress.

Event Description

Description of event according to article: first, intervention to the proximal right coronary artery was performed without complication.During preparatory valvuloplasty, slight aggravation of mitral regurgitation (mr) was seen.It was attempted to deploy a corevalve without rapid ventricular pacing.When the prosthetic valve started to expand, the systolic blood pressure dropped markedly.Severe mr was detected, and blood was blown out via the nasal airway.The corevalve was deployed smoothly at an acceptable position, with mild perivalvular leakage.Adjusting the position of the left ventricular guidewire (lunderquist extra-stiff wire guide) stabilized hemodynamics, and resulted in a reduction in mr.During hemostasis of the common femoral artery, bleeding from the nasal and oral cavity persisted.Both interventions were performed under a heparinized condition.Unfractionated heparin was neutralized with protamine sulfate.The authors of the article state that: "we experienced a case of bilateral pulmonary hemorrhaging caused by acute severe mr during tavi.During deployment of the corevalve, interference of the stiff guidewire with the mitral subvalvular structure caused transient severe mr.The elevated intra-cardiac pressure was transmitted from the left ventricle to the left atrium, pulmonary veins, lungs and pleural space, causing bilateral pulmonary hemorrhaging".It is further stated: "slight aggravation of mr was observed as the stiff guidewire was inserted, suggesting interference of the guidewire with the subvalvular structure.Stress to the guidewire generated by valve deployment led to transient severe mr.Mr regressed after valve deployment, suggesting no organic damage to the mitral valve".Patient outcome: no additional procedures were needed.However, bilateral pleural hematoma and left lung hemorrhaging was observed the day after the procedure.Pulmonary hemorrhaging continued to expand, but the bleeding was stopped by administration of vitamin k, fresh-frozen plasma and hemostatic drug.Respiratory failure was managed by non-invasive positive pressure ventilation.Pulmonary hemorrhaging gradually decreased in size and administration of a single antithrombotic with clopidogrel was continued.The patient's lung recovered its oxygenation capability, and the patient was discharged home on the 48th postprocedural day.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Exemption number (b)(4).William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# (b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: investigation is based on article review incl.Image review.It was reported that during deployment of a valve interference of the stiff wire guide with the mitral subvalvular structure caused transient severe mitral regurgitation (mr).Mr regressed after valve deployment, suggesting no organic damage to the mitral valve.No product was returned, but an image review demonstrated increased mr during aortic valve deployment compared to during valvuloplasty and the floppy tip of wire guide was close to the mitral valve.From valvuloplasty to stent deployment, the stiff part of the wire tip was advanced into the ventricle, too, likely to provide support for delivery system advancement.This advancement curved 165mm of wire into a left ventricle only 62mm deep.Deflection of the chordea tendineae and prevention of complete systole were mechanisms by which the guidewire could have caused transient mitral valve disfunction.Given an aortic valve annulus angle well within the ifu, up to 8cm of guide wire retraction should have been possible before deployment without changing the corevalve alignment with the aortic valve annulus.This would have prevented the pulmonary hemorrhage precipitated systolic pressure transmission into the pulmonary veins across the mitral valve.As stated in the article careful attention should be paid during tavi.Stress to the wire guide generated by valve deployment led to transient severe mr and particularly when deploying a transcatheter heart valve, the position of the wire guide, hemodynamic status and degree of mr must be monitored carefully.There is no evidence to suggest that this wire guide was not manufactured according to specifications and nothing indicates that it did not perform as intended.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: UNKNOWN
• Type of Device: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 8178145
• MDR Text Key: 130780091
• Report Number: 3002808486-2018-01528
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,other
• Type of Report: Initial,Followup
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/10/2018
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 05/28/2019
• Supplement Dates FDA Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 81 YR