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

Model Number	G38204
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	06/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer ref# pr(b)(4).Pma/510(k): p140016.Summary of investigational findings: a patient with aneurysm in thoracic aorta underwent thoracic endovascular repair, where it was planned to use a zta-pt-42-38-225-w (complaint device).The patient¿s anatomy was reported to be tortuous and outside of the recommendations in the instructions for use.Moreover, it was reported that the patient´s anatomy in the area of the landing zone was a tight-angled arch of aorta.During the preparation, the physician had noticed that device had a s-shaped form.It was reported that it was not easy to deploy the device and the physician had used a lot of force.However, the device was fully deployed, but the ideal landing zone was not achieved.When the device was pulled out from the patient, it was noticed that the dilator tip and the sheath were deformed.The additional device a zta-p-42-121-w was used.The patient had suffered retrograde dissection with tamponade and had to get emergent arch repair due to this occurrence.The patient had suffered a stroke, respiration and renal failure postoperatively.Based on the product evaluation, it was not be possible to determine the cause of the reported failure.Based on the provided information it is possible that the patient¿s tortuous anatomy contributed to the event.Cook medical will continue to monitor for similar events.
Event or Problem Description
Description of event according to initial reporter: a repair for a patient with a thoracic aneurysm was performed.The case started smoothly and access was not an issue.As the device was introduced to the table, the customer commented on the s-curves in the sheath due to the vertical storage of the device.The device was advanced on the wire and positioned for deployment.The device was then fully deployed, missing the ideal landing zone.The dilator tip and sheath were retracted out of the patient where the customer noted the white dilator showed sign of imperfection - attributing to the malfunction of the graft placement.Patient not covid positive.Was tight angled which you should be able to see on ct.Device was s shaped out of packaging and i brought it up several times because i was concerned.It would not deploy easily and took a lot of force and the device was like an accordion when it came out.Pulled back due to difficulty in deployment had to place additional graft.He had retrograde dissection with tamponade.Had to get emergent arch repair.Stroke, resp failure, renal failure postoperative still in house.Patient outcome: the case was continued, extending with an additional piece proximally.The case was completed without negative outcome to the patient.

• Brand Name: ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 11884312
• Report Number: 3002808486-2021-01279
• Device Sequence Number: 3633491
• Product Code: MIH
• UDI-Device Identifier: 10827002382043
• UDI-Public: (01)10827002382043(17)201206(10)E3662284
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/26/2021

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: 12/06/2020
• Device Model Number: G38204
• Device Catalogue Number: ZTA-PT-42-38-225-W
• Device Lot Number: E3662284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1