MAUDE Adverse Event Report: WILLIAM COOK EUROPE LUNDERQUIST EXTRA-STIFF CURVED EXCHANGE SUPPORT WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Catalog Number UNKNOWN

Device Problems Material Too Rigid or Stiff (1544); Positioning Problem (3009)

Patient Problems Chest Pain (1776); Pain (1994); Great Vessel Perforation (2152); Pericardial Effusion (3271)

Event Type  Injury  

Event Description

Description of event according to article: the article reports perforation of the descending thoracic aorta at the bended segment during a tavr procedure however, mechanism is unknown.Highly likely, a wire guide related issue.Patient outcome: the patient did require any additional procedures due to this occurrence.Three hours postprocedure, the patient experienced worsening chest and back pain and shortness of breath.Her electrocardiogram was normal.Echocardiography revealed good left ventricle function with no pericardial effusion.No gradient or insufficiency were noted on the aortic valve, and the septum appeared intact.Chest x-ray revealed large left pleural effusion and thus, ct angiography was promptly executed showing perforation of the descending thoracic aorta at the bended segment.A chest tube was inserted immediately at bedside, draining 1,100 ml of bloody effusion.Red packed cells and protamine sulphate were administered.Drug therapy was administered to keep systolic blood pressure at 100 to 120 mm hg.Chest drainage was maintained for 4 days draining a total of 1,500 ml.Ct angiography at day þ5 showed trivial effusion and aortic wall perforation site sealing, with bilateral nonobstructive thrombi in both main pulmonary arteries.No signs of right ventricular overload were noted, and the patient was hemodynamically stable while mildly dyspneic.Anticoagulation therapy with low molecular weight heparin was ensued, replaced a day later by full dose apixaban.Dyspnea was resolved and the patient was discharged on the ninth postoperative day.

Manufacturer Narrative

Manufacturers ref# (b)(4).Article: manevich, et al.2023.Thoracic aorta perforation treated conservatively after tavr in a patient with extremely tortuous aorta.Doi: https://doi.Org/10.1016/j.Jaccas.2022.101691.G4) pma/510(k): k220137.Investigation is still in progress.This report is required by the fda under 21cfr 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.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: the article reports perforation of the descending thoracic aorta at the bended segment during a tavr procedure.However, mechanism is unknown.Highly likely, a wire guide related issue.The lunderquist ® extra-stiff wire guide with unknown specifications/tip was not returned for investigation and based on the literature only it cannot be determined, if the reported perforation was a wire guide related issue.The instructions for use supplied with the lunderquist ® extra-stiff wire guides warn that, ¿if resistance is noted tactilely or visually under fluoroscopy, determine the cause and take appropriate steps to relieve the resistance to avoid the risk of vessel perforation.Advancement and withdrawal of the wire guide should be performed slowly and carefully¿.There are adequate controls in place to ensure that the type of device was manufactured to specifications.Cook was unable to conduct a review of the device history record, as the lot number of the complaint device was not provided for the investigation.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.

Event Description

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

• Brand Name: LUNDERQUIST EXTRA-STIFF CURVED EXCHANGE SUPPORT WIRE GUIDE
• Type of Device: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: alex rahbek ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 18776183
• MDR Text Key: 336178986
• Report Number: 3002808486-2024-00038
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 03/01/2024
• 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: 82 YR
• Patient Sex: Female