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

Catalog Number ZTA-P-28-201

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Fistula (1862); Septic Shock (2068)

Event Date 04/07/2022

Event Type  Death  

Manufacturer Narrative

Manufacturers ref# (b)(6) blank fields on this form indicate the information is unknown or unavailable.G4) similar to device marketed under pma/510(k): p140016 investigation is still in progress.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.

Event Description

Description of event according to study: on (b)(6) 2019, the patient underwent a thoracic endovascular aortic repair under general anesthesia for a thoracic aortic dissection type b, which was considered to be chronic (>90 days).The patient was hemodynamically stable and did not have an aortic rupture, and the dissection was not complicated by mal-perfusion.The patient was symptomatic with leg pain.The intervention was routine (planned).Hypotension was not induced during deployment, cardiac output reduction techniques were not utilized during the procedure, no spinal cord protection adjuncts were performed during the study procedure, and the patient received anticoagulants during the procedure.The procedure angiography revealed the study device(s) were patent after the graft was completely implanted.There was no evidence of device issue(s) at the completion of the procedure.There was a type ib (distal) endoleak present at completion of the procedure (b)(6), fda ref# (b)(4).The location of graft material of proximal edge of the most proximal component was zone 3: first 2cm distal to left subclavian artery.The location of graft material of distal edge of the most distal component was above the celiac.The proximal location of dissection was zone 0: ascending aorta to innominate artery.The distal location(s) of dissection was the left common iliac artery.The thoracic false lumen was patent with source of false lumen flow as a secondary tear location specified as abdominal.The abdominal false lumen was patent with a secondary tear location specified as abdominal.On 03jun2019 (6 days post-procedure), the patient¿s follow-up ct revealed no progression of dissection and no development of a new entry tear.The proximal location of dissection was zone 5: mid descending aorta to celiac.The most distal zone of dissection was zone 10: common iliac arteries.The thoracic false lumen was partially thrombosed with a source of false lumen flow as a secondary tear, location specified as abdominal.The abdominal false lumen was patent with a secondary tear location specified as abdominal.The maximum diameter in the ascending aorta was 39 mm.The maximum diameter in the aortic arch was 37 mm.The maximum diameter in the descending thoracic aorta included a true lumen of 14 mm and a false lumen of 27 mm (41 mm total).The abdominal aorta included a true lumen of 7 mm and a false lumen of 22 mm (total 29 mm).The study devices were patent, there was not any evidence of thrombus, there was no evidence of device issues.There was a type ib (distal endoleak) present (b)(6), fda ref# (b)(4).On (b)(6) 2019 (70 days post-procedure) the patient underwent a staged procedure of t-branch placement.There is no additional information regarding this procedure.On (b)(6) 2019 (71 days post-procedure) the patient experienced paraparesis.Treatment included a spinal cord drain.The event was considered resolved with sequelae on (b)(6) 2019 and the site noted "patient has to use a rollator." the event was considered not related to the study device and not related to the study procedure.The event was considered to be related to the treated aortic disease.The site indicated that no other conditions or circumstances caused or contributed to this event.On (b)(6) 2019 (72 days post-procedure) a follow-up ct revealed no progression of dissection and no development of a new entry tear.The proximal location of dissection was zone 8: renal to infra renal abdominal aorta.The most distal zone of dissection was zone 10: common iliac arteries.The thoracic false lumen was completely thrombosed.The abdominal false lumen was partially thrombosed with a secondary tear location specified as abdominal.The maximum diameter in the ascending aorta was 28 mm.The maximum diameter in the aortic arch was 30 mm.The maximum diameter in the descending thoracic aorta included a true lumen of 18 mm and a false lumen of 24 mm (42 mm total).The abdominal aorta included a true lumen of 15 mm and a false lumen of 16 mm (total 31 mm).The study devices were patent, there was not any evidence of thrombus, there was no evidence of device issues.There was a type ii endoleak present.On (b)(6) 2020 (314 days post-procedure) a follow-up ct revealed no progression of dissection and no development of a new entry tear.The proximal location of dissection was zone 5: mid descending aorta to celiac.The most distal zone of dissection was zone 10: common iliac arteries.The thoracic false lumen and abdominal false lumen was not present.The morphology (dissection) diameters were unknown.The study devices were patent, there was not any evidence of thrombus, there was no evidence of device issues.There was no evidence of endoleak.On (b)(6) 2022 (1078 days post-procedure) a follow-up ct revealed no progression of dissection and no development of a new entry tear.The proximal location of dissection and distal zone of dissection were unknown.The thoracic false lumen and abdominal false lumen were not present.The morphology (dissection) diameters were unknown.The study devices were patent, there was not any evidence of thrombus, there was no evidence of device issues.There was no evidence of endoleak.On (b)(6) 2022 (1075 days post-procedure) the patient experienced an aorto esophageal fistula and the location relative to the study stent was at the stented segment.Treatment included antibiotics.The site has not answered whether the event is considered related to the study device, study procedure, treated aortic disease, or whether any other condition or circumstance caused or contributed to this event.The event led to in-patient hospitalization from (b)(6) 2022 and ultimately was associated with patient death.The event was unresolved at the time of patient¿s death on (b)(6) 2022 (this complaint).This event was located at the stented segment location and as such was considered reasonably possible to have a relationship with the study device at this time and notification thus prompted.Patient outcome: on (b)(6) 2022 the patient died.The cause of death was septic shock.The site noted "septic shock due to aorto esophagus fistula." an autopsy was not performed, and a death report is not available.

Event Description

Additional information received 27dec2023: the site informed that the event is considered to be not related to the study device and not related to the study procedure.The event is considered to be related to the treated aortic disease.The site indicated that no other conditions or circumstances caused or contributed to this event.

Manufacturer Narrative

Manufacturer ref# (b)(4).Additional information received form hospital that the event is considered to be not related to the study device and not related to the study procedure.The event is considered to be related to the treated aortic disease.The site indicated that no other conditions or circumstances caused or contributed to this event.The event is therefore no longer considered reportable 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 COMPONENTS
• 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: henriette s. christiansen ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 18281909
• MDR Text Key: 329895852
• Report Number: 3002808486-2023-00290
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002346847
• UDI-Public: (01)10827002346847(17)220506(10)E3848504
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2023

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 Expiration Date: 05/06/2022
• Device Catalogue Number: ZTA-P-28-201
• Device Lot Number: E3848504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 12/27/2023
• Supplement Dates FDA Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2019
• 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
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 62 KG