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

Catalog Number ZTA-P-28-109-W1

Device Problems Material Frayed (1262); Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Similar to device under 510(k)/pma: p140016.Investigation is still in progress.

Event Description

Description of event according to initial reporter: the intended use of the device was for tevar.Also, the access was gained from the right femoral artery, and the target sited was the descending thoracic aorta.First, zta-pt-32-28-178-w1 (lot: e3825843) was advanced over a lunderquist (double curved) and placed.However, endoleak type1b was observed ((b)(4)).Then, the physician attempted to place zta-p-28-109-w1(lot: e3776862) at the distal site as an additional treatment, but he removed it from the patient¿s body once because he felt resistance.He found that the sheath tip was desquamated like as frayed ((b)(4)).Therefore, he exchanged the complaint zta-p-28-109-w1(lot: e3776862) with zta-pt-32-28-201-w1 (lot: e3855198) considering the risk of vascular damage.Consequently, the disappearance of endoleak was confirmed, and the procedure was completed.Patient outcome: the patient reportedly experienced no adverse effects.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: an 82 year old female patient underwent surgery to treat her thoracic aortic aneurysm.A zta-pt-32-28-178-w1 was implanted.Endoleak type 1b was observed (b)(4).To treat the endoleak the physician attempted to implant zta-p-28-109-w1(complaint device) as a distal extension, however he felt resistance an removed it.He found that the sheath tip was frayed.He replaced the device with zta-pt-32-28-201-w1.The disappearance of the endoleak was confirmed, and the procedure was completed with no adverse effect to the patient.It was reported that implant access was from the right femoral artery and that the diameter of the vascular lumen was more than 7,5mm, with a little calcification.The doctor comments that the first implant zta-pt-32-28-178-w1 could be advanced without resistance although it was thinner than the complaint device.Provided photos of the product shows dents and a fold at the tip of the sheath.The product evaluation found several dents and pressure marks on the distal end of the sheath.Per the product evaluation, a likely cause for the reported event could be due to advancing the device in tortuous and calcified anatomy.Review of the device history record gave no indication of the device being produced outside of specifications.Per the instruction for use the device should be inspected prior to use.The ifu state: ¿inspect the device and packaging to verify that no damage has occurred¿ and ¿if damage has occurred, do not use the product, instead, return the product to cook.¿ furthermore, the ifu describes to stop and asses the cause, if resistance is felt when advancing the system, ¿exercise particular care in areas of e.G.Calcified vessels.¿ a likely cause for this event is related to patient anatomy, as it was reported that the access vessel had calcifications and the product evaluation found that the damage at the tip of the sheath was likely due to contact with calcified vessels.However as another device could be advanced without resistance and information about inspection prior to use was not available, an exact cause cannot be established.Cook medical will continue to monitor for similar events.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

No additional information regarding the patient and/or event has been received since previous medwatch report was sent.

• Brand Name: ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 8792652
• MDR Text Key: 151768275
• Report Number: 3002808486-2019-00994
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002449425
• UDI-Public: (01)10827002449425(17)210925(10)E3776862
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 07/09/2020

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: 09/25/2021
• Device Catalogue Number: ZTA-P-28-109-W1
• Device Lot Number: E3776862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2019
• Initial Date Manufacturer Received: 06/24/2019
• Initial Date FDA Received: 07/16/2019
• Supplement Dates Manufacturer Received: 07/08/2020
• Supplement Dates FDA Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 47