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

Catalog Number UNKNOWN

Device Problems Collapse (1099); Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Based on journal article: bandorski et al."endograft collapse after endovascular treatment for thoracic aortic disease." cardiovasc intervent radiol.2010 jun;33(3):492-7.This complaint is related to (b)(4) also based on article.Catalog# is unknown but referred to as cook zeniththoracic device.(b)(4).Investigation is still in progress.

Event Description

Description of event according to article: the patient was treated endovascularly for a taa located directly distal to the origin of the left subclavian artery (lsa).A 42 x 220 mm tubular endograft (zenith, cook, taa) was inserted.A ct scan 4 days post procedure showed a distal collapse of the endograft without clinical symptoms.Ct after 2 months revealed a persistent endoleak.Angiography showed a retrograde perfusion of the aneurysm sac due to incomplete sealing at the collapsed distal stent-graft, with filling of the lsa.Transbrachial embolization of the origin of the lsa with multiple platinum coils was performed, followed by thrombosis of the aneurysm sac.Ct at 54 months showed a stable aneurysm diameter.Patient outcome: the stent graft showed distal collapse which lead to endoleak.This was treated by embolization of the lsa.

Event Description

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

Manufacturer Narrative

Manufacturer ref#: (b)(4).Investigation concludes that the device is most likely a tx1 (ztege-42-220) device.The device is obsoleted and therefore not marketed in us.Therefore the event is no longer considered reportable.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: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 8900423
• MDR Text Key: 154545650
• Report Number: 3002808486-2019-01212
• Device Sequence Number: 1
• Product Code: MIH
• 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: 04/22/2020

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
• Initial Date Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 08/16/2019
• Supplement Dates Manufacturer Received: 04/16/2020
• Supplement Dates FDA Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention