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

Catalog Number UNKNOWN

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 10/14/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Investigation is still in progress.

Event Description

Description of event according to the initial reporter: physician informs about a patient who has had a thoracic stent from cook and physician believes the bare stent has broken off.Additional information 15oct2021: the patient has a zenith alpha from 2018 and was therefore recently operated on due to a proximal rupture with a material defect.The patient was operated a few times for undersizing of the first stent in the old, and later dissociation of the material distally.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: a female patient underwent tevar in 2018 where a zta and zteg device was implanted.According to the sales representative a physician informs that the bare stent of the zta device is broken off.Further information received states, the patient has a zenith alpha from 2018 and was therefore recently operated on due to a proximal rupture with a material defect.The patient was operated a few times for undersizing of the first stent in the old, and later dissociation of the material distally.It is reported that relining off the zta is performed due to this occurrence.An imaging review was made of the provided angiography.The imaging reviewer confirms that the bare alignment stent has separated from the stent graft, furthermore, the imaging reviewer discover that the bare stent has a facture.Per the findings of the imaging review "the proximal bare spring appears partially separated from the 1st sealing stent.The bare spring appears attached to the fabric at 1 suture point on the greater curve side.There also appears to be a single fracture in the spring.The remaining stent segments of the zta graft appear intact." and "distally, a zteg graft has minimal overlap with the distal zta graft".Based on these findings the imaging reviewers impression is "the cause of this component separation and fracture cannot be determined from the imaging provided." and "the report mentions a recent operation ¿due to a proximal rupture with material defect,¿ and that the patient had multiple previous interventions as well.It is unclear if the zta graft was manipulated or affected during these procedures." a review of the device history record could not be made, as the lot number was not provided.It is unclear what the following statement refer to: "the patient has a zenith alpha from 2018 and was therefore recently operated on due to a proximal rupture with a material defect.The patient was operated a few times for undersizing of the first stent in the old, and later dissociation of the material distally".Further clarification is requested but have not been provided.Based on the limited information and imaging review it is not possible to establish a cause for the event.In addition suture breakage and stent facture is both listed as potential adverse effects in the instruction for use.No evidence to suggest that the product was not manufactured 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.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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 ; 56868686
• MDR Report Key: 12696289
• MDR Text Key: 278382795
• Report Number: 3002808486-2021-01900
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/11/2022

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/14/2021
• Initial Date FDA Received: 10/26/2021
• Supplement Dates Manufacturer Received: 05/11/2022
• Supplement Dates FDA Received: 05/11/2022
• 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 Sex: Female