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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number ZTA-P-32-155
Device Problems Leak/Splash (1354); Insufficient Information (3190)
Patient Problems Aneurysm (1708); Death (1802); Fistula (1862)
Event Date 05/20/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4). Investigation is still in progress.

 
Event Description

Description of event according to study: on (b)(6) 2016, the patient received one proximal component: zta-p-32-155, lot # e3381987. No additional procedures or devices were needed. The patient was discharged from the hospital on (b)(6) 2016. On (b)(6) 2016 (26 days pp), the one-month follow-up ct was completed. There were no endoleaks or other problems noted. On (b)(6) 2016 (63 days pp), the patient was noted to have an aortobronchial fistula which was not related to the study device or procedure. On (b)(6) 2016 (65 days pp), the patient underwent a secondary intervention to treat a distal type i endoleak and the aortobronchial fistula. A distal extension was placed. Following the si, a distal type i endoleak remained. On (b)(6) 2016 (72 days pp), the patient was discharged from the hospital. On (b)(6) 2016 (135 days pp), the patient died at home. The cause of death is unknown and an autopsy was not performed. Patient outcome: the patient died at home on (b)(6) 2016 (135 days pp).

 
Manufacturer Narrative

Manufacturer ref# (b)(4). Summary of investigational findings: the investigation of this complaint was only based on the information provided in the event description along with history record of the device. The description of event states that the patient received one proximal component and was thereafter discharged. According to the ifu sent with the product, the use of this product requires the use of a distal component also as the zenith alpha thoracic endovascular graft is a two-piece cylindrical endovascular graft consisting of proximal and distal components. The use of two components provides active fixation at both the proximal and distal seal sites. This explains the appearance of type ib endoleak. The second reported event relates to the occurrence of aortobronchial fistula. Aortobronchial fistula is a potentially lethal complication secondary to the repair of a descending thoracic aneurysm addressed in the ifu as an adverse event. Lastly, it is not possible to determine if the reported death event is related to the device or pathological changes. Nothing indicates that the device was not manufactured according to spec or did not perform as intended. Cook medical will continue to monitor for similar events.

 
Event Description

Description of event according to study: on (b)(6) 2016, the patient received one proximal component: zta-p-32-155, lot # e3381987. No additional procedures or devices were needed. The patient was discharged from the hospital on (b)(6) 2016. On (b)(6) 2016 (26 days pp), the one-month follow-up ct was completed. There were no endoleaks or other problems noted. On (b)(6) 2016 (63 days pp), the patient was noted to have an aortobronchial fistula which was not related to the study device or procedure. On (b)(6) 2016 (65 days pp), the patient underwent a secondary intervention to treat a distal type i endoleak and the aortobronchial fistula. A distal extension was placed. Following the si, a distal type i endoleak remained. On (b)(6) 2016 (72 days pp), the patient was discharged from the hospital. On (b)(6) 2016 (135 days pp), the patient died at home. The cause of death is unknown and an autopsy was not performed. Patient outcome: the patient died at home on (b)(6) 2016 (135 days pp).

 
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Brand NameZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov DK-46-32
DA   DK-4632
56868686
MDR Report Key5905938
MDR Text Key53072755
Report Number3002808486-2016-00988
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberP140016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,O
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/17/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/26/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberZTA-P-32-155
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date08/18/2016
Device Age6 mo
Event Location No Information
Date Manufacturer Received08/19/2016
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/02/2015
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: 08/26/2016 Patient Sequence Number: 1
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