MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number ZDEG-P-32-82-PF

Device Problems Off-Label Use (1494); Malposition of Device (2616); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Event Date 10/06/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturers ref#: (b)(4).G4) similar to device marketed under pma/510(k): p180001.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) 2020, during the index procedure, a zdeg-pt-32-82-pf (lot#: e3956367) was implanted without difficulty.The degree of oversizing was 20%.Procedural angiogram showed no endoleak.Other devices that were also implanted during the study procedure: endoproth zenith ext corps, ref 13021009, esbe-32-58-zt.Endoproth vasculaire graft, non-cook.Endoproth vasculaire graft, non-cook.Endoproth vasculaire graft, non-cook.7x75 non-cook graft.7x32 non-cook stent.9x38 non-cook stent.Primary indication for implant was aortic aneurysm.Pre-procedural imaging done 13 days pre-procedure showed all vessels patent.Prior to the study device deployment, a superior mesenteric artery (sma) stent and left renal stent were implanted.The study graft was implanted within the coeliac.The procedure was done percutaneously via right and left femoral access site.No balloon was used during the procedure.The graft fabric did not cover the left subclavian artery.The device was patent without any separation or device integrity issues.There was no evidence of branch vessel obstruction at the completion of the procedure.On (b)(6) 2020, (two days post procedure) a computed tomography (ct) was done.All vessels that were assessed were patent.No endoleak was present.The study device was patent, and no device integrity issues, or separation of the device or evidence of migration had been reported.On (b)(6) 2020, (13 days post procedure) a ct revealed type ia proximal endoleak.It is stated the devices involved were the zenith ext esbe 32-58-zt and zdeg-p-32-82.It was also noted that there was a type ii endoleak present.The study device was patent and there was no device integrity issues, migration or separation of devices.On (b)(6) 2020, it was reported the patient experienced a deterioration of general condition.Treatment included change of medication and palliative treatment which resulted in the patient¿s death.Patient outcome: pt died on (b)(6) 2020 unrelated to the study procedure.

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).Summary of investigational findings: an 88-year-old male patient who had an endovascular procedure performed for an aortic aneurysm on (b)(6) 2020.The patient was previously endovascularly treated for an aortic arch aneurysm on (b)(6) 2018.Pre-procedural imaging done 13 days pre-procedure showed all vessels patent.Prior to the study device (zdeg) deployment, a sma stent and left renal stent were implanted.The study graft (zdeg) was implanted within the coeliac.It is noted that the zdeg (complaint device) was implanted without difficulty.The degree of oversizing was 20%.The patient also had an esbe 32-58-zt and bridging stents implanted.The procedure was done percutaneously via right and left femoral access site.No balloon was used during the procedure.The graft fabric did not cover the left subclavian artery.The device was patent without any separation or device integrity issues.There was no evidence of branch vessel obstruction at the completion of the procedure.Procedural angiogram showed no endoleak.On (b)(6) 2020 (two days post procedure) a ct was done.All vessels that were assessed were patent.No endoleak was present.The study device (zdeg) was patent, and no device integrity issues, or separation of the device or evidence of migration had been reported.On (b)(6) 2020 (13 days post procedure) a ct revealed type ia proximal endoleak.It is stated the devices involved were the esbe 32-58-zt and zdeg-p-32-82.It was also noted that there was a type ii endoleak present.The study device (zdeg) was patent and there was no device integrity issues, migration or separation of devices.No information was provided regarding the endoleaks and follow-up/considerations on treatment.On (b)(6) 2020 it was reported the patient experienced a deterioration of general condition.Treatment included change of medication and palliative treatment.It is stated in the information that the patient died on (b)(6) 2020 unrelated to the study procedure and was exited from study.The patient had pre-existing medical conditions including a history of myelodysplastic syndrome, type ii diabetes, stage 3 chronic kidney disease, hypertension, asa class 3 (a patient with severe systemic disease).Review of the device history record gave no indication of the device being produced out of specification.As patient death is reported in the complaint a clinical assessment is performed by medical advisor.As per clinical assessment, following comments were noted: "there is no detailed information regarding the deterioration of general condition, but the site specifically stated it was unrelated to the study procedure.And the patient was multimorbid and of advanced age.Nothing in the provided information indicates a fault device.It is assumed that the type ia endoleak is related to the proximal end of the zdeg (if it was between the components, esbe and zdeg if would have been assumed defined as type iii endoleak).There is no information on secondary intervention/follow-up plan regarding the type i endoleak.From the information there is no indication that either the type ia or type ii endoleaks were involved in the patient¿s deterioration and subsequent death." it is reported that the type 1a endoleak involves both the zdeg and esbe, several attempts to obtain additional information with regards to, whether there is more than one endoleak and implantation location of the devices are made, but no response to the questions are provided.Based on the limited provided information it has not been possible to determine a cause for the type 1a endoleak.In addition it is noted that the device is used to treat an aortic aneurysm which is outside the intended use for this device.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 TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT
• 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; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: henriette s. christiansen ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 17304167
• MDR Text Key: 319014547
• Report Number: 3002808486-2023-00193
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002242729
• UDI-Public: (01)10827002242729(17)230226(10)E3956367
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/18/2023

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: 02/26/2023
• Device Catalogue Number: ZDEG-P-32-82-PF
• Device Lot Number: E3956367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2023
• Initial Date FDA Received: 07/12/2023
• Supplement Dates Manufacturer Received: 09/11/2023
• Supplement Dates FDA Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2020
• 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): Life Threatening
• Patient Age: 88 YR
• Patient Sex: Male
• Patient Weight: 73 KG