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

Model Number	G35367
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: a (b)(6) old male patient underwent a tvar procedure in which the zenith alpha thoracic endovascular graft proximal components, g35367, was used.The last graft piece, (b)(4), was used for bridging between two grafts as the proximal graft was too short with the distal piece.When the physician finished and rotated the delivery system the nose cone of the device inner white cannula came off and stayed on the wire end of the graft.Leaving the nose cone and inner cannula in the patient.The physician then advanced a longer and larger sheath and snared the sheath to remove from the patient.Additional information received 20mar2020: after releasing the stent graft, the physician retrieved the inner system and left the outer sheath in order to perform ballooning.When the inner system was taken out, it was noted that the system only contained the grey positioner along with the handle and the tip assembly (dilator tip and cannula) was left in patient.There was very torturous anatomy and we were well in the arch around zone 2.Some difficulty retrieving device over the arch but as expected with the anatomy and size of aneurysm.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
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: a 66-year-old male patient underwent tevar where a zta-p-42-173-w was inserted around zone 2 in the aortic arch.The anatomy was reported to be very torturous.When the physician rotated the handle to release the stent graft, the tip assembly came off and stayed on the wire end of the graft.The physician advanced a longer and larger sheath and snared it around the tip assembly to remove it from the patient.The zta device was returned without shipping stylet, stent-graft and distal part of the inner cannula tube.Per the product evaluation, the cannula was fractured.Glue was found in the pin vise.It has not been possible to determine why the cannula was separated from the pin vise.Review of the device history record gave no indication of the product being produced out of specification.It has not been possible to determine when in the process the cannula fractured, however, the product evaluation found that the roughness of the fracture indicated that the fracture occurred outside the patient.Based on the provided information and evaluation of the returned product it has not been possible to establish an exact cause for the separation of the cannula from the pin vise.It was reported that the anatomy was tortuous which might have contributed.Cook medical will continue to monitor for similar events.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.

• Brand Name: ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL 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: 9909215
• Report Number: 3002808486-2020-00381
• Device Sequence Number: 14267224
• Product Code: MIH
• UDI-Device Identifier: 10827002353678
• UDI-Public: (01)10827002353678(17)230113(10)E3938709
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P140016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/13/2023
• Device Model Number: G35367
• Device Catalogue Number: ZTA-P-42-173-W
• Device Lot Number: E3938709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2020
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 12/09/2020
• 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: Required Intervention
• Patient Age: 66 YR