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	G32592
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Death (1802); Rupture (2208)
Date of Event	09/29/2020
Type of Reportable Event	Death
Event or Problem Description
A (b)(6) female patient underwent a zenith fenestrated graft placement for a abdominal aortic aneurysm in which the zenith fenestrated aaa endovascular graft was used.The case went as standard.In the right iliac limb the physician used a gore graft as initially planned.After placed the stent looked like it was narrowed so the physician put down kissing stents and ballooned at the narrowing.The balloon was a bard balloon and used 14 mm on the right and used 12 mm on the left.At this time the patient blood pressure started to drop.The physician realized ruptured the aorta when ballooned.A coda balloon was put down and slowed the leak.Physician did an angiogram and saw contrast leaking at the bifurcated area.The physician placed another gore graft down to the fenestrated to realign the leg and seal it off.Just under the renal stents another gore graft was placed to re-stent lowest right renal to reassure no leaking around there.The patient was given a unit of blood and would stabilize, then blood pressure would drop and patient was given another unit of blood to stabilize; was done during procedure to keep patient stabilized.The district manager due to schedule left during the procedure, however followed up for an update on (b)(6) 2020-- the patient's blood pressure continued to not stabilize.Physician stated the ina had torn off from the aorta and the patient was anti-coagulated at this point in the procedure to where the blood was so thin it was leaking through the suture holes of the grafts and the patient expired.The physician noted that there was some calcification around the bifurcated area.Further clarification was received.When physician was using the bard balloons to expand the iliac limbs a tear occurred in the cook bifurcated built in limb.The bp started to drop and an angiogram was performed.You could see the contrast go through the graft and into aneurysm and out into abdomen.The physician then used a gore limb to reline the cook built in limb.
Additional Manufacturer Narrative
The device was not returned for evaluation.Images were provided and reviewed by medical director at william cook australia.The medical director stated that ¿this resulted in an endoleak, that was observed to be extending not only into the abdominal aortic aneurysm (aaa) sac, but also though the sac into the abdomen.In other words, they had a leaking aaa.¿.The md stated that this is not a fault or failure of the cook device.The cook device was torn by the use of bard balloons inside gore iliac grafts that then stretched and tore the bifurcation of the zfen-d.It is feasible that the calcification around the bifurcation may have torn the zfen-d when the kissing balloons were inflated, pushing the graft onto the calcified plaques.Work order (b)(4) was reviewed and appears complete and correct.There are a number of processes and checks in place at william cook australia to ensure that loose/damaged graft material/sutures/knots are identified prior to shipment.Based on the information received it is difficult to determine an exact root cause.It is possible that one or more of the following factors contributed to the complaint: patient/procedural factors (e.G.Calcification around the bifurcation may have torn the zfen-d when the kissing balloons were inflated, pushing the graft onto the calcified plaques).
Event or Problem Description
A 78 year old female patient underwent a zenith fenestrated graft placement for a abdominal aortic aneurysm in which the zenith fenestrated aaa endovascular graft was used.The case went as standard.In the right iliac limb the physician used a gore graft as initially planned.After placed the stent looked like it was narrowed so the physician put down kissing stents and ballooned at the narrowing.The balloon was a bard balloon and used 14mm on the right and used 12mm on the left.At this time the patient blood pressure started to drop.The physician realized ruptured the aorta when ballooned.A coda balloon was put down and slowed the leak.Physician did an angiogram and saw contrast leaking at the bifurcated area.The physician placed another gore graft down to the fenestrated to realign the leg and seal it off.Just under the renal stents another gore graft was placed to re-stent lowest right renal to reassure no leaking around there.The patient was given a unit of blood and would stabilize, then blood pressure would drop and patient was given another unit of blood to stabilize; was done during procedure to keep patient stabilized.The district manager due to schedule left during the procedure, however followed up for an update on (b)(6) 2020.The patients blood pressure continued to not stabilize.Physician stated the ina had torn off from the aorta and the patient was anti-coagulated at this point in the procedure to where the blood was so thin it was leaking through the suture holes of the grafts and the patient expired.The physician noted that there was some calcification around the bifurcated area.Further clarification was received.When physician was using the bard balloons to expand the iliac limbs a tear occurred in the cook bifurcated built in limb.The bp started to drop and an angiogram was performed.You could see the contrast go through the graft and into aneurysm and out into abdomen.The physician then used a gore limb to reline the cook built in limb.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY
• Common Device Name: 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: 10681898
• Report Number: 9680654-2020-00032
• Device Sequence Number: 304456
• Product Code: MIH
• UDI-Device Identifier: 10827002325927
• UDI-Public: (01)10827002325927(17)230901(10)AC1064877
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2023
• Device Model Number: G32592
• Device Catalogue Number: ZFEN-D-16-62-76-C
• Device Lot Number: AC1064877
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 12/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 78 YR