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

Catalog Number ZDES-46-185

Device Problems Fracture (1260); Material Fragmentation (1261); Off-Label Use (1494); Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Description of event according to initial reporter: during the control before hospital discharge, physician has noticed that the 2 last stent of zdes seems detached patient outcome: every pieces of the endograft is still inside the patient without problems for him.Patient is very well.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did experience any adverse effects due to this occurrence.

Manufacturer Narrative

Manufacturer ref# (b)(4).Similar to device marketed under pma/510(k): p180001.Investigation is still in progress.

Manufacturer Narrative

Manufacturer ref# (b)(4).After investigation the event for this pr# is no longer reportable.It has not been possible to establish a casual relationship between the device and the reported event in which no harm has been reported.The imaging reviewer cannot confirm the separation but rater thinks it is the flexibility of the stent, that is the reason, the 2 last stents seems detached on imaging.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: ZENITH® DISSECTION ENDOVASCULAR STENT
• Type of Device: 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, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 14425276
• MDR Text Key: 293847221
• Report Number: 3002808486-2022-00322
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002342610
• UDI-Public: (01)10827002342610(17)250221(10)E4226423
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZDES-46-185
• Device Lot Number: E4226423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2022
• 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): Life Threatening
• Patient Sex: Male