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

Catalog Number UNKNOWN

Device Problem Collapse (1099)

Patient Problem Chest Pain (1776)

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Article: pontón, a., et al."spontaneous re-expansion of a collapsed thoracic endoprosthesis: case report." j vasc surg.2008 dec;48(6):1585-8.Investigation is still in progress.

Event Description

Description of event according to article: the patient was treated for type b aortic dissection.The entry tear in the descending thoracic aorta was approximately 6 cm above the celiac trunk.A 32 x 124 mm zenith stent graft was implanted by tevar.Complete occlusion of the false lumen from the subclavian artery to the celiac trunk was achieved.However, intense chest pain developed 36 hours after the procedure and imaging showed filling of the false proximal lumen.The reopened false lumen had caused compression of the true aortic lumen and collapse of the proximal third of the stent graft.There were no objective signs of visceral and peripheral malperfusion and a conservative approach was followed.A control scan 7 days later showed normal diameter of the true aortic lumen as well as full re-expansion of the stent graft.Follow-up scans after hospital discharge confirmed the absence of leaks and stent graft migration or collapse, but progressive dilatation of the descending thoracic aorta was observed.For this reason, a second procedure was performed 18 months post-procedure to cover this segment with a new zenith stent graft (32 x 140 mm) through the previous stent graft.The patient¿s postoperative course was uneventful, and she was asymptomatic 8 months after the procedure.Patient outcome: the patient had a second procedure at 18 months after the first procedure due to dilatation of the aorta (aneurysm).The patient experienced intense chest pain due to compression of the true lumen and the stent graft.The reopening of the false lumen was possibly due to a new proximal entry tear.

Manufacturer Narrative

Manufacturer ref# (b)(4).According to the investigation the zenith stent graft is most likely a tx1 (ztege-32-124) device which have been obsolete for a number of years (ce mark removed in 2006), it is concluded that no similar device is marketed in us and the event is therefore not reportable in us.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: 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: 8904995
• MDR Text Key: 154722079
• Report Number: 3002808486-2019-01224
• 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: 08/27/2020

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: 07/26/2019
• Initial Date FDA Received: 08/19/2019
• Supplement Dates Manufacturer Received: 08/17/2020
• Supplement Dates FDA Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening