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

Model Number	G35359
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: there appears to be a type 1a endoleak at the proximal end of the alpha thoracic graft, just distal to the l.Subclavian artery (lsa).The final set of images we have are from (b)(6) 2019, and these show that the proximal type 1a endoleak has been fixed by extending the alpha graft proximally to cover the lsa, the lsa itself has been coil embolized to prevent backflow, and the extension of the graft back into the arch has been fixed using aptus screws into the aortic wall.On (b)(6) 2019: proximal extension of thoracic endograft with a cook zta-pt 42 x 38 covering the left subclavian artery, placement of thoracic endograft cook zta-p 38 x 167 between the connection of the previous tevar and branch graft.Placement of 3 aptus screws in the proximal thoracic stent graft.Coil embolization of left subclavian artery.Per (b)(4) (manufacturer report # 3002808486-2021-01881): (b)(6) 2019: proximal extension of thoracic endograft with a cook zta-pt 42 x 38 covering the left subclavian artery, placement of thoracic endograft cook zta-p 38 x 167 between the connection of the previous tevar and branch graft.Placement of 3 aptus screws in the proximal thoracic stent graft.Coil embolization of left subclavian artery.Balloon angioplasty of superior mesenteric artery stent and left renal artery stent with a 10 x 2 balloon.
Additional Manufacturer Narrative
Manufacturer ref# pr350542 after investigation the event is no longer considered reportable.Summary of investigational findings: this complaint was opened to address type 1a endoeleak and was opened based on findings in an imaging review performed for complaint pr343291 which address type 3a endoleak.Per the findings of the imaging review ¿there appears to be a type 1a endoleak at the proximal end of the alpha thoracic graft, just distal to the l.Subclavian artery (lsa).¿ the following is the information which is provided for the original complaint (pr343291 manufacturer ref: 3002808486-2021-01881) on (b)(6)2017, a 67-year-old female patient underwent an endovascular procedure in which a zta-p-38-167-w (complaint device, manufactured at william cook europe) and a custom made device fen-thoraco-abdominal-graft (cmd) (manufactured at william cook australia) was implanted along with additional abdominal stent-graft devices.As per information received, the zta- and cmd components separated 823 days later on 20may2019.Cook was notified of this event through an excel spreadsheet made available to cook by cleveland clinic.On (b)(6)2019, a proximal extension of the thoracic endograft was performed with a cook zta-pt 42 x 38 covering the left subclavian artery, placement of thoracic endograft cook zta-p 38 x 167 between the connection of the previous tevar and branched graft, and placement of 3 aptus screws in the proximal thoracic stent graft.Coil embolization of left subclavian artery is also noted and balloon angioplasty of superior mesenteric artery stent and left renal artery stent with a 10 x 2 balloon.It is further noted that the patient tolerated the procedure.This complaint is related to wca complaint and wce complaints pr343291 (zta-p-38-167-w, type 3a endoleak) and pr351552 (type 2 endoleak).Review of device history record gave no indication of the device being produced outside of specifications.Five ctas (dated (b)(6)2016, (b)(6)2017, (b)(6)2018, (b)(6)2019 and (b)(6)2019) including pre-procedure, post-procedure and follow-up imaging, and procedural angiography packages (dated (b)(6)2016, (b)(6)2019) were provided for the investigation.Imaging analysis was performed by imaging specialists at cook research incorporated (cri) and a clinical review was performed by wca medical director.As per imaging analysis, the following measurements were noted: 07sep2016: diameter of aorta at lsa 34.6 mm.20may2019: diameter of aorta at lsa 38.5 mm as per clinical assessment, following comments were noted: "first, there appears to be a type 1a endoleak at the proximal end of the alpha thoracic graft, just distal to the l.Subclavian artery (lsa)." "the final set of images we have are from (b)(6) 2019, and these show that the proximal type 1a endoleak has been fixed by extending the alpha graft proximally to cover the lsa, the lsa itself has been coil emobolized to prevent backflow, and the extension of the graft back into the arch has been fixed using aptus screws into the aortic wall"."the top of the alpha thoracic graft developed a type 1a endoleak, most likely due to the progressive extension of the aneurysmal disease into the proximal landing zone." based on the provided information and findings in the imaging review it is assessed that the event of type ia endoleak is caused by disease progression.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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
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: this complaint was opened to address type 1a endoeleak and was opened based on findings in an imaging review performed for complaint (b)(4) which address type 3a endoleak.Per the findings of the imaging review ¿there appears to be a type 1a endoleak at the proximal end of the alpha thoracic graft, just distal to the l.Subclavian artery (lsa).¿ the following is the information which is provided for the original complaint ((b)(4) manufacturer ref: 3002808486-2021-01881) on (b)(6) 2017, a 67-year-old female patient underwent an endovascular procedure in which a zta-p-38-167-w (complaint device, manufactured at william cook europe) and a custom made device fen-thoraco-abdominal-graft (cmd) (manufactured at william cook australia) was implanted along with additional abdominal stent-graft devices.As per information received, the zta- and cmd components separated 823 days later on (b)(6) 2019.Cook was notified of this event through an excel spreadsheet made available to cook by cleveland clinic.On (b)(6) 2019, a proximal extension of the thoracic endograft was performed with a cook zta-pt 42 x 38 covering the left subclavian artery, placement of thoracic endograft cook zta-p 38 x 167 between the connection of the previous tevar and branched graft, and placement of 3 aptus screws in the proximal thoracic stent graft.Coil embolization of left subclavian artery is also noted and balloon angioplasty of superior mesenteric artery stent and left renal artery stent with a 10 x 2 balloon.It is further noted that the patient tolerated the procedure.This complaint is related to wca complaint and wce complaints (b)(4) (zta-p-38-167-w, type 3a endoleak) and (b)(4) (type 2 endoleak).Review of device history record gave no indication of the device being produced outside of specifications.Five ctas (dated (b)(6) 2016, (b)(6) 2017, (b)(6) 2018, and (b)(6) 2019) including pre-procedure, post-procedure and follow-up imaging, and procedural angiography packages (dated (b)(6) 2016, (b)(6) 2019) were provided for the investigation.Imaging analysis was performed by imaging specialists at cook research incorporated (cri) and a clinical review was performed by wca medical director.As per imaging analysis, the following measurements were noted: (b)(6) 2016: diameter of aorta at lsa 34.6 mm.(b)(6) 2019: diameter of aorta at lsa 38.5 mm.As per clinical assessment, following comments were noted: "first, there appears to be a type 1a endoleak at the proximal end of the alpha thoracic graft, just distal to the l.Subclavian artery (lsa)." "the final set of images we have are from (b)(6) 2019, and these show that the proximal type 1a endoleak has been fixed by extending the alpha graft proximally to cover the lsa, the lsa itself has been coil emobolized to prevent backflow, and the extension of the graft back into the arch has been fixed using aptus screws into the aortic wall"."the top of the alpha thoracic graft developed a type 1a endoleak, most likely due to the progressive extension of the aneurysmal disease into the proximal landing zone." based on the provided information and findings in the imaging review it is assessed that the event of type ia endoleak is caused by disease progression.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.

• 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
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 13151228
• Report Number: 3002808486-2022-00002
• Device Sequence Number: 14489835
• Product Code: MIH
• UDI-Device Identifier: 10827002353593
• UDI-Public: (01)10827002353593(17)191025(10)E3510679
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P140016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/25/2019
• Device Model Number: G35359
• Device Catalogue Number: ZTA-P-38-167-W
• Device Lot Number: E3510679
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2022
• Supplement Date Received by Manufacturer: 09/14/2022; 09/14/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 09/14/2022; 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown