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

Model Number G47493

Device Problems Mechanical Jam (2983); Physical Resistance/Sticking (4012)

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

Event Date 12/15/2021

Event Type  Death  

Event Description

Description of event according to initial reporter: while trying to remove the trigger wires, they could not be removed - and for this reason the device twisted.The wires were eventually removed after some manipulation.The graft was delivered and implanted successfully.Patient outcome: part of the delivery system remain inside the patient's body.The grey positioners' top cap remains inside the patient.After the initial procedure, the patient recovered that week.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The patient did not require any additional procedures due to this occurrence.

Manufacturer Narrative

Manufacturer ref# (b)(4).Pma/510(k): p180001.Investigation is still in progress.

Manufacturer Narrative

Manufacturer 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 Description

Additional information received on 31jan2022: the top cap has not been retrieved.Devices used or implanted during the procedure: zta-p-36-209-zt, lot# e4144964 coda-2-9.0-35-120-32 argon medical devices atrieve vascular snare kit.Petticoat was advanced from femoral access to the desired location in the thoracic aorta.Once three stents of overlap was achieved, the anti-torque was released.The device was them unsheathed to the distal end.The physician attempted to release trigger wires via unscrewing the white thumb screw and pulling back on the green trigger wire handle but was unsuccessful.After multiple attempts of trying to remove the green wire handle, the physician unscrewed the white cap to expose the inner cannula and trigger wire lumen.He was then able to pull back on the trigger wires directly with snaps.

Manufacturer Narrative

Manufacturer 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.H11: correction h1) serious injury.

Event Description

Additional information from meeting 29mar2022.A petticoat procedure was performed in which a zdeg device was placed successfully followed by a zdes device (complaint device).When trying to take of the trigger wire it wasn¿t pulling off.One physician tried, but thought it was stuck.All focus changed to the delivery system.They were trying to remove the green handle knob and trying a lot, without success.A second surgeon tried to no avail.While manipulating the system, the delivery system turned and twisted which caused the stent to candy wrap/houglass.No one noticed this because they were focusing on the delivery system entirely.That section of the stent was not in the fluoro.Petticoat might have gone down to celiac.While manipulating they couldn´t identify the cause of issue with the green trigger knob.Md's were advised to remove green knob and remove the trigger wires manually.The trigger wires came off.When pulling out the grey delivery system part (grey positioner) the stent was twisted as candy wrap.The dilator couldn¿t release from the stent, where the stent was candy wrapped.The stent was fully released from the delivery system, when trying to pull out the delivery system the dilator tip was stuck in the candy wrap.Senior surgeons were called.Advised to cut the grey dilater as proximal as possible until patient was able to undergo open repair to explant the delivery system.The patient was not able to undergo open repair currently, due to disease state.Stent was folded and turned like a candy wrap / hourglass and containing some of the delivery system.Top cap refers to white dilator tip.Approx.4-6 days later the patient suffered an aortic rupture and expired.Patient expired before an open repair/secondary procedure was performed.It is believed that the rupture may be due to extensive manipulation.

Event Description

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

Manufacturer Narrative

Manufacturer ref# (b)(4).H11) corrected data compared with medwatch report mw5108534: d1) stent endo zenith thoracic 36x180mm - log572316.D3) cook medical llc.D4) udi: not releasable.D6a) not releasable.E1) name and address of initial reporter: (b)(6).E3) no.H6) health effect - clinical code: 2687.Medical device problem: 1536.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 petticoat procedure was performed to treat a type b aortic dissection.Zta-p or zdeg (?) device was placed successfully followed by a zdes device (complaint device).Three stents of overlap were achieved.The physician attempted to release trigger wires via unscrewing the white thumb screw and pulling back on the green trigger wire handle but was unsuccessful.One physician tried, but thought it was stuck.A second surgeon tried too.While manipulating the system, the delivery system turned and twisted which caused the stent to candy wrap/hourglass.No one noticed this because they were focusing on the delivery system entirely.That section of the stent was not in the fluoro(scopy).Petticoat might have gone down to celiac.While manipulating they couldn´t identify the cause of issue with the green trigger knob.Md´s (medical doctor) were advised to remove green knob and remove the trigger wires manually.The trigger wires came off.When pulling out the gray delivery system part (gray positioner) the stent was twisted as candy wrap and the dilator tip was stuck in the candy wrap.Senior surgeons were called.Advised to cut the grey dilater (cannula tube) as proximal as possible until patient was able to undergo open repair to explant the delivery system.The patient was not able to undergo open repair currently, due to disease state.Stent was folded and turned like a candy wrap / hourglass and the dilator tip remained inside the patient.Approx.4-6 days later the patient suffered an aortic rupture and expired.Patient expired before an open repair/secondary procedure was performed.It is believed that the rupture may be due to extensive manipulation.The complaint device was returned for evaluation.The device was returned in four separate parts.Returned was 1) the sheath with a part of the cannula tube inside, 2) gray positioner with rotation handle, 3) most of the trigger wires and 4) green release knob with a part of the trigger wires.The performed evaluation found groove marks from trigger wires on the main body handle going from the wire hole and 180 degrees round until reaching the end of the handle (releasing the green release knob).Additional, scrape-off was observed on the trigger wires that were still attached to the green release knob.These observations indicates that the green release knob was rotated during retraction.Rotation of the green release knob during retraction will catch the nitinol wires between the handle and green release knob and cause the green release knob to get stuck on the handle.The evaluation confirmed that only a part of the cannula tube was returned.This was visible by the length of the cannula, which was around the same length as the sheath incl.Captor valve.Both ends of the cannula tube showed sign of being cut or broken.The uat and dilator tip were missing in the proximal end and the hub was missing in the distal end of the cannula tube.Moreover circumferential compressions and damages on the sheath, were observed during device evaluation and were possibly caused during the struggle to get the dilator tip out of the candy wrapped stent.Clinical assessment by a medical specialist was performed on the information in the complaint file.According to the clinical assessment it is not possible to establish an exact cause to the aortic rupture.But there seems to be a relatively close timeline between the endovascular procedure with its complications and the aortic rupture.Due to the described complication with the stuck green knob and resulting entangled delivery system inside the turned stent it seems possible that vessel trauma could have occurred, due to manipulation of devices, and then could have progressed over the following days until the rupture.It could be speculated if the remaining cannula could have caused the rupture, but it seems inappropriate to draw any conclusion on this.According to the ifu i-dissect-system-411-01eu for the device: ¿loosen the safety lock from the green trigger-wire release mechanism.Withdraw the trigger-wire until the proximal end of the device opens.Do not rotate the green trigger-wire knob.(fig.15) the distal end is still attached.Continue to withdraw the trigger-wire until the distal end opens.Withdraw the trigger-wire completely.As the distal end of the stent is still attached to the introduction system do not move the gray positioner until both ends of the stent are fully released.Note: check to make sure that the trigger-wire is removed prior to withdrawal of the introduction system".Moreover, aortic rupture and death is listed in the ifu as a known potential adverse event.Based on the complaint event information, clinical assessment and the evaluation of the returned device, there is a strong probability that the green release knob was rotated during retraction.This caused the trigger wires to get caught between the green release knob and handle, which complicated any movement of the green release knob.It is reasonable to think that the struggling with removing the green release knob caused the zdes stent to get candy wrapped, which lead to the decision to cut the grey dilator/cannula tube.There seems to be a relatively close timeline between the endovascular procedure with its complications and the aortic rupture.However, what caused the aortic rupture is still unknown.An internal action is in progress to handle difficulties/inabilities in withdrawing the green trigger wire mechanism.No evidence to suggest that the device 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.

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: 13117508
• MDR Text Key: 282958416
• Report Number: 3002808486-2021-02051
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002474939
• UDI-Public: (01)10827002474939(17)240812(10)E4145541
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/14/2022

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 Model Number: G47493
• Device Catalogue Number: ZDES-36-180-US
• Device Lot Number: E4145541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 01/31/2022; 03/29/2022; 04/20/2022; 07/11/2022
• Supplement Dates FDA Received: 02/21/2022; 04/19/2022; 05/09/2022; 07/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2021
• 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 Outcome(s): Death; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male