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

Catalog Number TBE-42-81-PF

Device Problems Device Damaged Prior to Use (2284); Failure to Advance (2524)

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

Event Date 01/04/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Similar to device under 510(k) p070016.Summary of investigational findings: unfortunately due to the limited information provided it has not been possible to conclude an exact root cause for this event.However nothing indicates that the device was defective.Furthermore, the package insert states under users precautions - "if the packaging has been opened prior to use, or there is damage or contamination, and if abnormalities such as damage to the component can be seen, do not use the device." cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: the devices were used for treatment of aortic dissection by an advising doctor's instruction though it was off-label use.Ax - ax bypass was performed and the procedure was conducted with zteg-2p-36-152-pf (distal site) + zteg-2pt-42-158-pf (proximal site), approached from the right femoral artery.Since confirmatory angiography confirmed proximal type i endolak near zteg-2pt-42-158-pf, the physician decided to place tbe-42-81-pf as an additional treatment ((b)(4)).Preparation for tbe-42-81-pf placement was made as usual, and the delivery system was inserted from the right femoral artery.However because it would not advance, the physician checked the tip of the delivery system and noticed that the sheath was curled up.He decided not to use the device to avoid damaging vascular wall with the curled part that could produce another dissection ((b)(4)).Type i endoleak was considerably reduced by re-ballooning.Therefore, no more additional treatment was performed and the physician decided to take a wait-and-see approach ((b)(4)).Patient outcome: there has been no adverse effects reported.

• 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; 4632 bjaeverskov; DA
• Manufacturer Contact: marianne hoey ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 6334890
• MDR Text Key: 67544442
• Report Number: 3002808486-2017-00477
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002526560
• UDI-Public: (01)10827002526560(17)150824(10)E2966910
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/04/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TBE-42-81-PF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2013
• Date Device Manufactured: 08/24/2012
• 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