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

Catalog Number UNKNOWN

Device Problems Off-Label Use (1494); Device Dislodged or Dislocated (2923); Pressure Problem (3012)

Patient Problems Vascular Dissection (3160); Unspecified Vascular Problem (4441)

Event Type  Injury  

Manufacturer Narrative

Manufacturers ref# (b)(4).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 Description

Patient underwent tevar with stent-graft coverage from 2 cm distal to the lsca to the celiac artery.Two ztas are used.The proximal graft landed 2.5 cm distal to the intended landing site (lsa).At 6 weeks post-operation, cta revealed focal retrograde dissection.The proximal zta had migrated 2 cm further distally and was now 4.5 cm (the article says mm, but it must be cm) distal to the lsa.Endovascular reintervention is performed to place two stent grafts from an other manufacturer.Patient outcome: there was imprecise deployment, graft migration and retrograde dissection.

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).Article: poorly sized tevar: implications and lessons learned.Dalal et al.2021 doi: 10.21037/acs-2021-taes-87 summary of investigational findings: during a literature review cook became aware of the article ¿poorly sized tevar: implications and lessons learned¿.This article is a case report describing a 68-year-old male patient with history of hypertension, asthma and obstructive sleep apnea presented with sharp chest pain.Medications on admission included four antihypertensives (metoprolol, losartan, nifedipine, and spironolactone) and prednisone.Computed tomography angiogram (cta) demonstrated uncomplicated type b intramural hematoma (imh) from the left subclavian artery (lsca) to the abdominal aorta.Eighteen days following his original dissection, the patient re-presented with unrelenting, sharp chest and back pain, despite systolic blood pressure of 130 mmhg and pulse rate of 70 beats per minute.Cta revealed evolution of type b imh with focal dissection in the distal descending thoracic aorta (dta).He underwent thoracic endovascular aortic repair (tevar) with a zta-p-40-167 and a zta-pt-38-34-167.The aorta was measured to 35.1 mm in diameter at the left subclavian artery (lsa) and 32.1 mm 3 cm distally leading to a 14-20% oversized sealing throughout the 2 cm landing zone.Post-operative cta demonstrated exclusion of the focal dissections in the distal dta, reduced imh thickness and no complications, however it was reported that the zta-p-40-167 was deployed 2.5 cm distally to the intended proximal landing zone at lsa.At 6-weeks follow-up cta the stent-graft was positioned 4.5 mm (likely typo should have been cm) from the lsa it was reported that this was due to migration.Vessel diameter of the proximal aorta, had grown from 38 to 49 mm.It is speculated that this might be due to the oversized stent-graft.It is noted that the 38 mm is not mentioned in relation to the measurements given for the diameter at implant site.The patient underwent a secondary procedure were two additional stent-grafts were placed immediately distal to the lsa and into the zta-p-40-167.Per the instructions for use the zenith alpha thoracic endovascular graft is indicated for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta having vascular morphology suitable for endovascular repair.The safety and effectiveness of the zenith alpha thoracic endovascular graft and ancillary components have not been evaluated in the patient populations with dissection.The imh in this article is described as a dissection and the use of the zta as an off-label choice.It is assessed that it is likely that the migration and enlargement of the vessels occurred due to the off-label use of the device.Cook medical will continue to monitor for similar events.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
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 15453489
• MDR Text Key: 300224250
• Report Number: 3002808486-2022-00959
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male