MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G38178
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: "following placement of the fenthoraco abdominal component the alpha was advanced into position, overlapping a previously implanted alpha thoracic graft & the just implanted fenthoraco component.When deployed and trigger wires removed, the most proximal stent was not fully expanded, the appearance was as though it was being constrained.A coda balloon was then advanced over the lunderquist wire and inflated a total of three times.After the second and third inflation the proximal stent fully deployed with complete apposition with the previously implanted alpha component." patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
Additional information received from rep on 05aug2019: there were no difficulties in removing the delivery system.We did observe the shape of the proximal alpha immediately and used a coda to open it.After inflating a second time the proximal graft ¿popped¿ open and had good apposition then.
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).Investigation is still in progress.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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Summary of investigational findings: expansion difficulties related to the proximal stent were experienced during the implant procedure of a zta-pt-36-32-161-w in a 72 year old female patient.Following placement of a fenthoraco abdominal component the alpha was advanced into position, overlapping a previously implanted alpha thoracic graft and the just implanted fenthoraco component.When the complaint device had been deployed and trigger wires removed, the most proximal stent was not fully expanded, the appearance was as though it was being constrained.A coda balloon was then advanced over the lunderquist wire and inflated a total of three times.After the second and third inflation the proximal stent fully deployed with complete apposition with the previously implanted alpha component.No adverse effects to the patient have been reported.As per additional information, there were no difficulties in removing the delivery system, and good apposition was observed after ballooning.A single fluoroscopic image provided in two copies were available for the investigation, and reviewed by an expert imaging reviewer.As per imaging review, on the image, the released zta-pt-36-32-161-w was partially expanded.The introducer tip had been retracted into the zta-pt-36-32-161-w proximal end.The bare stent was funneled and tipped either anterior or posterior as two of its apices were imaged completely on end.The bare stent wires had partially slid into a funneled sealing stent.A fenthoraco component proximal apex bowed towards the zta-pt-36-32-161-w bare stent sealing junction likely because it had caught the base of the zta-pt bare stent.Had the zta-pt-36-32-161-w deployed in this location, it would have not overlapped into the pre-existing proximal endograft but deployed only in the fenthoraco component.The tipped bare stent occurred in a straight segment of the proximal descending thoracic aorta.The imaging reviewer commented that insufficient zta-pt-36-32-161-w insertion into the pre-existing proximal component, inward bowing of a fenthoraco component proximal apex on the zta-pt, tipping and funneling of the zta-pt bare stent, sliding of the bare stent into the zta-pt sealing stent, and funneling of the zta-pt sealing indicate that the zta-pt was pulled down after unsheathing but before release.The deployment sequence to be followed is listed in the instructions for use (ifu) below "directions for use" and "placement of proximal component".As per step 10, the gray positioner (introduction system shaft) should be stabilized during withdrawal of the sheath until the graft is fully expanded and the valve assembly with the captor sleeve docks with the black gripper.Step 11 directs to verify graft position and, if necessary, adjust it forward.Recheck graft position with angiography.As per sequence listed in steps 12 to 14, steps to be followed to open the uncovered stent and proximal end of the graft and release of the distal attachment to the introducer, should be performed prior to removal of the introduction system.In addition to this, as per warnings and precautions in the ifu, repositioning the stent graft distally after partial deployment of the covered proximal stent may result in damage to the stent graft.The complaint is confirmed based on the provided information and image.It has not been possible to establish a definitive cause for this complaint founded in the information and single image provided.However, as per imaging review, it cannot be excluded that downward/distal repositioning of the device after unsheathing but before release potentially contributed to the event.Incomplete component deployment is listed as a potential adverse event in the ifu.Cook will reopen the complaint if further information is received.No evidence to suggest that the product was not manufactured according to specifications.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: ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 8825898
• Report Number: 3002808486-2019-01077
• Device Sequence Number: 19437453
• Product Code: MIH
• UDI-Device Identifier: 10827002381787
• UDI-Public: (01)10827002381787(17)211001(10)E3778643
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P140016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2021
• Device Model Number: G38178
• Device Catalogue Number: ZTA-PT-36-32-161-W
• Device Lot Number: E3778643
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 08/05/2019; 04/08/2020
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 08/27/2019; 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1