MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH® DISSECTION ENDOVASCULAR STENT; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number G47493

Device Problems Loss of or Failure to Bond (1068); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/06/2022

Event Type  malfunction  

Event Description

Description of event according to initial reporter: a (b)(6) patient underwent a tevar with distal extension with bare aortic dissection stent in aortic arch, descending aorta, abdominal aorta procedure in which the zenith dissection endovascular stent, zdes-36-180-us, was used.Another zdes was deployed proximal and this device was being deployed to extend distally to the abdominal aorta, the device was deployed in the patient and the surgeon went off fluoro and removed the delivery system, when coming back on flouro both devices had been pulled down to the abdominal aorta.The devices had been deployed through a gore dry seal sheath.When the surgeon pulled the dry seal out the distal device came all the way out of the patient.No apparent effect to patient was noticed.The device (zdes) came out of the patient through the access point when the surgeon removed the dry seal sheath through which it had been introduced.Patient outcome: the surgeon implanted another zdes stent to cover the target area.The only delay was due to selecting another stent to treat the target areas and was minimal with no apparent impact.

Manufacturer Narrative

Manufacturer ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.G4) pma/510(k): (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.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: a 73-year-old male patient underwent a tevar with distal extension with bare aortic dissection stent in aortic arch, descending aorta, abdominal aorta procedure in which the zenith dissection endovascular stent, was used.Another zdes was deployed proximal and this zdes-36-180-us (complaint device) was being deployed to extend distally to the abdominal aorta, the complaint device was deployed in the patient and the surgeon went off fluoro and removed the delivery system, when coming back on flouro both devices had been pulled down to the abdominal aorta.The devices had been deployed through a dry seal sheath from another manufacturer.When the surgeon pulled the dry seal out the distal device came all the way out of the patient.No apparent effect to patient was noticed.The surgeon implanted another zdes stent to cover the target area.The device (zdes) came out of the patient through the access point when the surgeon removed the dry seal sheath through which it had been introduced.The only delay was due to selecting another stent to treat the target areas and was minimal with no apparent impact.For further elaboration it was requested whether the distal zdes has been completely released from the introduction system prior to the physicians attempt to remove the introduction system and why did removal of the dry seal sheath cause the devices to get ¿pulled¿ into the abdominal aorta? the following was the sales representative opinion ¿i do not believe so.I saw him (physician) fully unsheath the device and was watching the screen for him to turn fluoro back on, but when he did not turn it back on i turned around i caught a glimpse of what appeared to be him pulling down on the device but i cannot be certain as it was only a split second.He then pulled out the thumb screw and trigger wire and removed the system.¿ i believe he (physician) pulled down the delivery system down before fully releasing the device, as explained above.I think that ended up pulling the distal end of the stent into the dry seal before he (physician) released it and when he pulled the dry seal out, the distal zdes was in the dry seal and came down with it, also pulling down the proximal zdes.Review of the device history record gave no indication of the device being produced out of specification.The stent was returned and a device evaluation was performed.During device evaluation it was observed that the second and third stent were partly separated from each other due to absence of the sutures on three apexes.Furthermore tissue was present on the suture between the first and second stent.Based on the device evaluation it is possible that the sutures broke when the stent was pulled out of the patient.As the introduction system was not returned for evaluation, it was not possible to evaluate and determine the cause of the reported event.Per the sales representatives opinion it is possible that the introduction system was pulled down into the dry seal sheath before the stent was fully deployed, furthermore it appears that fluoroscopy was turned of when the stent was deployed and the introduction system was removed from the patient.According to the ifu "as the sheath is withdrawn, anatomy and graft/stent position may change.Constantly monitor graft position and perform angiography to check position as necessary." based on the provided information it could be assumed that the reported event is related to the introduction system being pulled down before the stent was fully released, which caused the stent to get caught inside the dry seal sheath.Cook will reopen the investigation if further information or imaging is received.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: ZENITH® DISSECTION ENDOVASCULAR STENT
• 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
• MDR Report Key: 14742806
• MDR Text Key: 295109944
• Report Number: 3002808486-2022-00834
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2022

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
• Device Operator: Health Professional
• Device Model Number: G47493
• Device Catalogue Number: ZDES-36-180-US
• Device Lot Number: E4129371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2022
• Initial Date FDA Received: 06/20/2022
• Supplement Dates Manufacturer Received: 12/22/2022
• Supplement Dates FDA Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2021
• 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 Age: 73 YR
• Patient Sex: Male