MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH® DISSECTION ENDOVASCULAR STENT; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	ZDES-36-80-US
Medical Device Problem Codes	Off-Label Use (1494); Use of Device Problem (1670); Difficult to Advance (2920)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).G4) pma/510(k): p180001 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.
Event or Problem Description
Description of event according to initial reporter: zdes-36-80-us lot e4358915 did not have a smooth tip to sheath transition and therefore could not be advanced into a sheath.Device was not deployed.Patient outcome: the complainant did not report any adverse effects to the patient due to this occurrence.
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).B5 has been updated with additional information.Investigation is still in progress.Cook medical will continue to monitor for similar events.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.
Event or Problem Description
Additional information received 01mar2024: the device could not be advanced past the valve.The device could not be advanced into a sheath that was already in the body.A prior device was able to be advanced through the sheath and also a subsequent device.The device in question kept catching and could not be advanced.
Additional Manufacturer Narrative
Manufacturers ref (b)(4) after investigation the event for this pr# is no longer reportable.Summary of investigational findings: a patient with a type a dissection was about to be treated with a zdes-36-180-us (complaint device).As reported the zdes-36-180-us did not have a smooth tip to sheath transition and therefore could not be advanced into a valve of 18fr gore dry seal sheath that was already in the body.Device was not deployed.A prior device was able to be advanced through the sheath and a subsequent device a zdes-36-120-us.The complaint device kept catching and could not be advanced.As a result, the patient experienced a slight case delay.The physician had to examine device and tried to advance several times.The physician also then had to wait for an additional device to be prepped.No adverse effects have been reported on the patient due to this occurrence.Per the reported information the device was inspected prior to use and was prepped as normal.No flaw was identified during preparation of the device and no damage was observed on the package.Review of the device history record gave no indication of the device being produced out of specification.Zdes-36-80-us was returned without protection tube and shipping stylet, and was evaluated.Device evaluation found that the outer diameter of the sheath was measured to 6.0mm and is within specifications.A divergent distance from dilator tip to tip of the sheath and a single compression were found on the sheath, which likely occurred because of resistance during introduction of the device through the valve of the gore dry seal sheath.Scrape off and few minor scratches were observed on one side of the proximal part of the dilator tip during evaluation.It cannot be determined when the scrape off and scratches occurred, but it may have been caused during attempt to advance the dilator tip through the valve of the gore dry seal sheath.Furthermore, as per that manufacturer's website: https://www.Goremedical.Com/products/dryseal/specifications visited on (b)(6) 2024, the minimum sheath id (inner diameter) for a 18fr gore dry seal sheath is 6.0mm and the same as outer diameter of the complaint device.It is reported that ¿zdes did not have a smooth tip to sheath transition and therefore could not be advanced into a sheath.¿ and ¿the device could not be advanced past the valve.¿ based on the provided information it is unclear if only the dilator tip could not be advance through the valve of the gore dry seal sheath or if the zdes got stuck in transition between the dilator tip and sheath in the valve due to the reported tip to sheath transition not being smooth.It should be noted that no damage of the proximal end of the sheath (transition between the dilator tip and sheath) was found during the device evaluation.Based on the provided information and device evaluation it has not been possible to establish an exact cause for the inability to advance the zdes through the gore dry seal sheath.But it cannot be excluded that as the gore dry seal sheath has the same inner diameter as outer diameter of zdes device, that this usage contributed to the resistance as inner to outer diameter difference was limited to about 0.0 mm.Cook will reopen the complaint if additional information is received.The ifu (instructions for use) requires that the zenith product line is used for implantation of zenith dissection endovascular stent during procedure, which includes cook check-flo® introducer sets.It is noted that zdes device was used for treatment of a type a dissection, which is outside of intended use for this type of device.According to ifu, the zenith dissection endovascular system is indicated for the endovascular treatment of patients with type b aortic dissection.Cook medical will continue to monitor for similar events.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ZENITH® DISSECTION ENDOVASCULAR STENT
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• 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: 18578103
• Report Number: 3002808486-2024-00012
• Device Sequence Number: 8926061
• Product Code: MIH
• UDI-Device Identifier: 10827002474915
• UDI-Public: (01)10827002474915(17)260118(10)E4358915
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/18/2026
• Device Catalogue Number: ZDES-36-80-US
• Device Lot Number: E4358915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/17/2024
• Supplement Date Received by Manufacturer: 03/01/2024; 06/28/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 03/26/2024; 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Female