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

Catalog Number GZSD-36-164-2

Device Problems Unintended Movement (3026); Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problems Vascular Dissection (3160); No Code Available (3191)

Event Date 08/07/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Similar to device under pma/510(k) p070016.(b)(4).Investigation is still in progress.

Event Description

Description of event according to study: (b)(6) 2015: to treat the aortic dissection, zteg-2pt-36-26-159-pf and gzsd-36-164-2 were placed.Since then, the chest false lumen was completely thrombus until the second year of follow-up.(b)(6) 2019: contrast ct was performed at four years follow up, and it was found that the stent graft migration toward to distal side, type i entry flow and false lumen enlargement (5 mm).Patient outcome: no additional procedure has been performed, and no additional procedure is planned.

Manufacturer Narrative

Manufacturer ref# (b)(4).Investigation is still in progress.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

Additional information received (b)(6) 2019: implant location of the listed devices zteg-2pt: the edge of the left subclavian artery.Distal end of gzsd was th9-10.About 4.5cm above celiac artery.True lumen diameter was 32.26mm compered to (b)(6) 2019, the vessel angulation was more severe on (b)(6) 2015.Originally, the stent graft was placed exactly the same size as aneurysm diameter (true lumen diameter 32.26mm).During long term follow up, the vessel lumen became dilated gradually 35.40mm, then migration occurred.A secondary tear in the thoracic aorta is indicated with location specified as cranial.Lesser curvature side.10mm distally side of the stent of the stent graft.10mm distally side of the stent of the stent graft.Actual distance of the migration is 10.7mm additional information received (b)(6) 2019: 10mm distally side of the sealing stent.

Event Description

Additional information received on 21jun2021: complaint device changes from zteg to gzsd.

Manufacturer Narrative

Manufacturer ref# (b)(4).After investigation the event for this pr# is no longer reportable.Zteg migration was not confirmed based on the provided four year imaging.The complaint of a new entry tear related to the gzsd stent is confirmed.A conclusive cause for the entry tear cannot be determined.Cook will reopen the complaint if further information is received.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: ZENITH DISSECTION ENDOVASCULAR STENT STENT
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 9127420
• MDR Text Key: 161695849
• Report Number: 3002808486-2019-01552
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002236070
• UDI-Public: (01)10827002236070(17)180122(10)E3295881
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,study
• Type of Report: Initial,Followup,Followup
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2018
• Device Catalogue Number: GZSD-36-164-2
• Device Lot Number: E3329040
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 67 YR