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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH® TX2® TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE ZENITH® TX2® TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number ZTEG-2PT-42-32-165-PF
Device Problems Leak/Splash (1354); Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Date 11/09/2017
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 study: (b)(4) was opened to cover component/component type 3a endoleak between zta-pt-44-40-179 and zteg-2pt-42-32-165-pf. On (b)(6) 2017 the patient received the following devices: zta-pt-44-40-179 (lot #e3601003) ((b)(4), bfarm ref# (b)(4)); tbranch-34-18-202 (lot #e3601459) ((b)(4), bfarm ref# (b)(4)); zteg-2pt-42-32-165-pf (lot #e3623804) ((b)(4) and (b)(4)); unibody-22-132 (lot #a1000126) distal body ; zsle-16-74-zt (lot #6384706) right iliac leg graft; zsle-20-74-zt (lot #6666996) left iliac leg graft. On the completion angiogram, the devices were patent with no device integrity issues. A type iv endoleak was noted. Additional information received on 06feb2018: the next day ((b)(6) 2017), the post-procedure follow-up ct was performed. A type ii endoleak was noted. No type iv endoleak was noted. The devices were patent with no device integrity issues ((b)(4)). Additional information received on 18apr2018: "the type iv endoleak observed was not related to the zta- device but for either the tranch- or the unibody" ((b)(4)). Additional information received 23jul2018 from imaging review: "the zta-pt and zteg-2pt type 3a endoleak was likely the result of pleating between the zteg-2pt sealing stent and the zta-pt. Although overlap was tree stent lengths, acute, greater than 90 degrees aortic angulation limited the zteg-2pt seal inside the zta-pt to the length of the zteg second mainbody stent ((b)(4))".

 
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Brand NameZENITH® TX2® TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer (Section G)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov DK-46 32
DA DK-4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov DK-46-32
DA   DK-4632
56868686
MDR Report Key7788086
MDR Text Key117256685
Report Number3002808486-2018-00920
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,OTHER,STUDY
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/01/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/16/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/30/2020
Device Catalogue NumberZTEG-2PT-42-32-165-PF
Device LOT NumberE3623804
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date08/08/2018
Device Age2 mo
Event Location No Information
Date Manufacturer Received10/16/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/30/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/16/2018 Patient Sequence Number: 1
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