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 Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: (b)(6).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 during implantation, the tip of the flexor sheath of a zenith flex aaa endovascular graft bifurcated main body scrunched up.Consequently, the device was not able to be implanted.The physician was unable to track the sheath into the patient.After pulling the delivery system out a bit, the physician noticed that the sheath had "advanced onto the dilator, creating a lip/shelf".However, it was able to be re-advanced smoothly.The device was then taken off of the wire and dilators were used to dilate the patient's vessels without issues.The physician then attempted to insert the main body device, but found that it was not tracking into the patient's groin.As the device was taken out, it was noted that the tip of the flexor sheath was "scrunched up".Another device was able to be "advanced perfectly" and was thus used to complete the procedure without issues.Heparin was administered intraoperatively.Posterior calcium was used at the access site.The patient's vessels were reported to have been greater than 8mm with the posterior calcium.The case was described to be "straight-forward and per ifu" and the graft was not altered in any way prior to use.A slight type 1b endoleak was noticed during the procedure on the right side, but was able to be corrected by re-ballooning.The rest of the procedure was completed "fine" without any adverse effects to the patient.The patient will have a 30-day follow-up ct scan.Additional information regarding the patient, device, and event has been requested but is currently unavailable.

Manufacturer Narrative

A1 - patient identifier: (b)(6).Additional information: b5.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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

In additional information received on 04feb2021, it was reported that the patient had several "cardiac cath procedures with groin access" prior to their aaa repair.As the slight type 1b enodleak was not resolved during the procedure, another event associated with this patient is also reported under patient identifier (b)(6) the patient was "doing fine" at their one-month follow-up where a ct scan was performed.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.A1 - patient identifier: j.S.- (b)(6) investigation - evaluation (b)(6) hospital informed cook on (b)(6) 2021 of an incident involving a zenith flex aaa endovascular graft bifurcated main body (tffb-28-96-zt) from lot 13462327.The tip of the delivery sheath was reportedly damaged during an attempted evar on (b)(6) 2021.Communication with the user facility clarified that the patient's access site was calcified.The patient reportedly experienced no adverse effects as a result of this incident.A review of the complaint history, device history record (dhr), drawing, instructions for use (ifu), and quality control, as well as a visual inspection of the returned device, was conducted during the investigation.One device was returned to cook for evaluation.A visual inspection found that the transition between the sheath and the dilator was not smooth.Cook has concluded that the device was manufactured to specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the dhrs for the reported complaint device lot (13462327) and the related device subassembly lots revealed no recorded non-conformances that could have contributed to the reported failure mode.As there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints have been received from the field, cook has concluded that there is no evidence suggesting that nonconforming product exists either in house or in the field.Cook also reviewed product labeling.The product ifu, [z_zaaaf_rev5] ¿zenith flex aaa endovascular graft with the z-trak introduction system,¿ provides the following information to the user related to the reported failure mode: ¿9 how supplied - the product is sterile if the package is unopened and undamaged.Inspect the device and packaging to damage that no damage has occurred as a result of shipping.Do not use the device if damage has occurred or if the sterilization barrier has been damaged or broken.If damage has occurred, do not use the product and return to cook.¿ based on the information provided, inspection of the returned device, and the results of the investigation, a definitive root cause for this event has been traced to the patient's condition.The calcified access site is likely the cause of failure for this event.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.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 the patient and/or event 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
• MDR Report Key: 11273960
• MDR Text Key: 258587505
• Report Number: 1820334-2021-00244
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002484181
• UDI-Public: (01)10827002484181(17)221009(10)13462327
• Combination Product (y/n): N
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2022
• Device Model Number: N/A
• Device Catalogue Number: TFFB-28-96-ZT
• Device Lot Number: 13462327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 02/04/2021; 08/13/2021
• Supplement Dates FDA Received: 02/05/2021; 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 16 FR. DILATOR; 18 FR. DILATOR; 32 CODA BALLOON; COOK PIGTAIL CATHETER; LUNDERQUIST WIRE QTY. 2; PRO-GLIDE CLOSURE DEVICES QTY. 2; TFFB-28-82-ZT; ZSLE-16-90-ZT; ZSLE-24-90-ZT
• Patient Age: 71 YR