MAUDE Adverse Event Report: COOK INC ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number N/A

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

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

Event Date 03/17/2022

Event Type  Injury  

Manufacturer Narrative

It should be noted that tffb- devices are distributed via one-device lots.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that the stent of a zenith flex aaa endovascular graft bifurcated main body separated from the graft material during an endovascular aortic aneurysm repair procedure.The separation was noted after the main body graft was deployed and connected to the contralateral iliac leg graft.The ipsilateral leg graft was not deployed when the breakage was noted.It was reported that no difficulty was experienced when removing the top cap and the distal/ipsilateral limb trigger was not released prior to advancement of the top cap.The patient underwent a laparotomy to remove the device.The patient stayed in the icu for one week and was discharged after returning to the general ward for one week.No other adverse effects were reported for this incident.

Manufacturer Narrative

Investigation ¿ evaluation: (b)(6) medical equipment company in china reported that after the main body graft and contralateral iliac leg graft were released, it was discovered that the ¿naked section of metal wire of graft¿ was broken.The complaint device was a zenith flex aaa endovascular graft bifurcated main body (rpn: tffb-24-82-zt, lot: 14040977).The male patient was 66 years old and weighed 65 kilograms at the time of the event.He had been diagnosed with an abdominal aortic aneurysm.The patient underwent endovascular aortic repair (evar) on 17mar2022.There was no angulation of the aneurysm neck relative to the long axis of the aaa.During the procedure, the following cook devices were implanted: zenith flex aaa endovascular graft bifurcated main body (rpn: tffb-24-82-zt, lot: 14040977) zenith flex aaa endovascular graft iliac leg (rpn: tfle-14-73-zt, lot number unknown) contralateral there was no difficulty experienced during the procedure when removing the top cap from the main body graft.The distal/ipsilateral limb trigger wire was not released prior to the advancement of the top cap.It was discovered that the suprarenal stent (described as the naked wire of aaa graft) had broken.The ipsilateral leg was not deployed when the breakage was discovered.The patient required a laparotomy to remove the stent.The patient stayed in the intensive care unit (icu) for one week and was discharged to the general ward for one week.Reviews of the documentation including the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control procedures and specifications, as well as a visual inspection of the returned device, were conducted during the investigation.One used main body graft (tffb) along with one leg graft (tfle) were returned for evaluation.A visual examination confirmed that the top stent of the tffb was broken.There was missing suture at one of the points of the internal stent.No other damage was noted to the grafts.Medical imaging was not provided for expert review.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that appropriate inspections are in place relative to the reported device failure.A review of the device history record (dhr) for lot 14040977, graft kit lot sa13474655 and top stent lot sa13484635 found no nonconformances that could have contributed to the reported failure mode.The graft subassembly lot (2100226.4) was sewn by approved vendor sei medical s.A., and upon incoming inspection, zero nonconformances were detected.Graft subassembly lot sa 13585659 had one nonconformance, but it was reworked and re-inspected prior to further processing.It should be noted that there were no other complaints associated with the final product lot number.Evidence provided by the complaint facility, device history record, complaint history, device failure analysis, manufacturing documents, and verification testing, suggests that the device was manufactured to specification.There is no evidence of nonconforming devices in house or in the field.Cook also reviewed product labeling.The device was packaged with ifu t_zaaaf_rev5.The ifu includes the following, warnings, precautions, and instructions for proper placement of the device.4 warnings and precautions.4.5 implant procedure.¿ do no bend or kink the delivery system.Doing so may cause damage to the delivery system and the zenith flex aaa endovascular graft.¿ to avoid any twist in the endovascular graft, during any rotation of the delivery system, be careful to rotate all of the components of the system together (from outer sheath to inner cannula).¿ do not continue advancing any portion of the delivery system if resistance is felt during advancement of the wire guide or delivery system.Stop and assess the cause of resistance; vessel, catheter or graft damage may occur.Exercise particular care in areas of stenosis, intravascular thrombosis or in calcified or tortuous vessels.¿ repositioning the stent graft distally after partial deployment of the covered proximal stent may result in damage to the stent graft and/or vessel injury.¿ fluoroscopy should be used during introduction and deployment to confirm proper operation of the delivery system components, proper placement of the graft, and desired procedural outcome.¿ as the sheath and/or wire guide is withdrawn, anatomy and graft position may change.Constantly monitor graft position and perform angiography to check position as necessary.¿ the zenith flex aaa endovascular graft incorporates a suprarenal stent with fixation barbs.Exercise extreme caution when manipulating interventional and angiographic devices in the region of the suprarenal stent.¿ avoid damaging the graft or disturbing graft positioning after placement in the event re-instrumentation (secondary intervention) of the graft is necessary.¿ before deployment of the suprarenal stent, verify that the position of the access wire guide extends just distal to the aortic arch.¿ verify that the predetermined contralateral iliac leg is selected for insertion on the contralateral side of the patient before implantation.5 adverse events.5.2 potential adverse events.¿ surgical conversion to open repair.After review of the ifu, cook has concluded the device labeling contains appropriate warnings, precautions and instructions to the user related to the reported failure.Based on the information provided, examination of the returned product and the results of our investigation, a definitive cause for the failure could not be established.The appropriate personnel have been notified.Per the risk assessment no further action is required.We will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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 patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 14118112
• MDR Text Key: 289331412
• Report Number: 1820334-2022-00577
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002484075
• UDI-Public: (01)10827002484075(17)230628(10)14040977
• Combination Product (y/n): N
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/22/2022

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 Expiration Date: 06/28/2023
• Device Model Number: N/A
• Device Catalogue Number: TFFB-24-82-ZT
• Device Lot Number: 14040977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/28/2022
• Initial Date FDA Received: 04/15/2022
• Supplement Dates Manufacturer Received: 07/12/2022
• Supplement Dates FDA Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2021
• 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
• Treatment: COOK TFLE-14-73-ZT.
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 65 KG