MAUDE Adverse Event Report: WILLIAM A. COOK AUSTRALIA, PTY LTD ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number G32551

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 05/20/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

According to the initial reporter, the proximal graft and the distal graft separated creating a type 3 endoleak.It was reported that the patient underwent intervention on (b)(6) 2020.It was further reported: yes surgical intervention was required.The distal fenestrated component lost its overlap with the proximal fenestrated component.The distal component migrated down into the aneurysm at a difficult angle posteriorly.Also, the right and left iliac limbs lost seal within the common iliacs and migrated up into the aneurysm.The distal fenestrated graft and limbs folded in the aneurysm making reintervention difficult.Physician accessed the axillary artery and put a 8fr sheath down into the aorta.He stented the sma with a gore 8x29 vbx and stented the left renal artery with a gore 6x29 vbx.He then drove a wire down into the proximal fenenstrated graft.He was able to snake the wire into the distal graft and through the left iliac limb.The physician accessed both femoral arteries and then from the left side snared the wire from above.Once he had wire access he exchanged it to a stiff wire which helped straighten out the folded graft.He then accessed the patients right femoral artery with a wire and was able to get access into the aorta from both sides.He decided to reline the graft with a gore excluder graft.All grafts remained inside the body.Physician was able to gain access to the device and reline our device with gore grafts.After the relining the grafts with the gore endografts an angiogram confirmed that the aneurysm was now sealed with no endoleak.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane QLD 4 113; AS QLD 4113
• MDR Report Key: 10119713
• MDR Text Key: 194034062
• Report Number: 3005580113-2020-00372
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002325514
• UDI-Public: (01)10827002325514(17)201103(10)AC1006353
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/04/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2020
• Device Model Number: G32551
• Device Catalogue Number: ZFEN-D-12-28-76-C
• Device Lot Number: AC1006353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/20/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/04/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/04/2020
• Date Device Manufactured: 11/03/2017
• 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: 64 YR