MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL EXTENSION; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number TBE-32-80-PF

Device Problems Bent (1059); Failure to Advance (2524)

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

Event Date 10/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Name and address for importer site: (b)(4).Similar to device under 510(k) p070016.(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: a (b)(6) male patient who previously received open repair with y-shaped graft in abdominal lesion (proximal 16mm, distal 9mm) underwent taa repair.The patient's anatomy was suitable for tevar.There was seen severe tortuousy on the patient¿s right artificial graft.On the left side, it was enough inner diameter (8mm) to pass the delivery system, therefore access was gained from the left.Zteg-2p-32-200-pf ((b)(4)) was advanced as planned from the left, however, the delivery system would not advance at tortuous lesion in the middle of artificial vessel.The physician attempted to advance the delivery system several times, however, under the fluoroscopic images, the delivery system seemed it shaped as it bent between the artificial graft and advancement force would not transmit to the delivery system, so the delivery system would not advance anymore.Then, another device tbe-32-80-pf ((b)(4)) was tried to pass through the artificial vessel to straighten, however the second delivery system would not advance due to the same reason of the first device.So, the physician considered to use another manufacture's device, but there is a risk of damage of anastomotic region of artificial graft due to outer sheath size (because others are larger than tx2), the physician discontinued the procedure.He repaired the access site to finish the procedure.Patient outcome: it is under consideration what procedure will be performed.There have been no adverse effect to the patient reported.

Manufacturer Narrative

Exemption number e2016032.(b)(4).Summary of investigational findings: the investigation of this complaint is based on description of event and one image of the product.This complaint concerns a patient with taa who previously received open repair with y-shaped graft in an abdominal lesion.Another tx2 device was first advanced in the left artificial vessel with an inner diameter of 8 mm.However, the delivery system would not advance through a tortuous lesion in the middle of artificial vessel.Then, the device of this pr was tried to pass through the artificial vessel to straighten, however the second delivery system would not advance due to the same reason as the first device.The physician discontinued the procedure.No imaging of patient anatomy was provided, to assess vessel tortuosity.However, the physician stated that the device likely got caught in the tortuous artificial vessel even though the diameter was sufficient for the introduction system.No evidence to suggest that the product was not manufactured according to specification.Cook medical will continue to monitor for similar events.

• Brand Name: ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL EXTENSION
• 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: 6982732
• MDR Text Key: 90393149
• Report Number: 3002808486-2017-02146
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002526515
• UDI-Public: (01)10827002526515(17)200920(10)E3631477
• 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: 01/15/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: TBE-32-80-PF
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/10/2017
• Device Age: 1 MO
• Initial Date Manufacturer Received: 10/10/2017
• Initial Date FDA Received: 10/27/2017
• Supplement Dates Manufacturer Received: 12/21/2017
• Supplement Dates FDA Received: 01/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 80 YR