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-42-225-W1

Device Problem Bent (1059)

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

Event Date 03/15/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Description of event according to initial reporter: a patient, who had had his/her ascending aorta replaced with blood vessel prosthesis before, underwent taa repair by right approach.The patient was suitable for the procedure.(there was no significant anatomical issue which could have contributed to the reported event confirmed.) the two devices were used for the procedure: zta-p-42-225-w1/ e3681060 (zone 1), zta-p-38-117-w1/ unknown (zone 4).When the physician released the trigger wire of zta-p-42-225-w1, the bare stent was deployed bent at approximately 90 degrees against lesser curvature of the vessel wall as if it was sticking in the vessel (*vessel perforation did not occur.).He managed to fix the bent by ballooning to complete the procedure.Patient outcome: there have been no adverse effcts to the patient reported.

Manufacturer Narrative

Exemption number e2016032.(b)(4).Summary of investigational findings: as per the reported information the patient underwent taa repair.The patient had at a previous timepoint had replacement of the ascending aorta with blood vessel prosthesis.During the procedure, the bare stent was deployed bent at approximately 90 degrees towards the inner aortic curvature.Subsequently the reported issue was corrected by ballooning.According to the reported information, the patient had suitable anatomy for the procedure and no adverse effects to the patient were observed.The placement of the device in zone 1 is outside the intended use and it can therefore not be determined if the placement in zone 1 did contribute to the reported event or bent.It was not possible to determine the exact cause or a likely cause of the reported event as no imaging was provided.No evidence to suggest that the device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: a patient, who had his/her ascending aorta replaced with blood vessel prosthesis before, underwent taa repair by right approach.The patient was suitable for the procedure.(there was no significant anatomical issue which could have contributed to the reported event confirmed.) the two devices were used for the procedure: zta-p-42-225-w1/ e3681060 (zone 1).Zta-p-38-117-w1/ unknown (zone 4).When the physician released the trigger wire of zta-p-42-225-w1, the bare stent was deployed bent at approximately 90 degrees against lesser curvature of the vessel wall as if it was sticking in the vessel (vessel perforation did not occur.).He managed to fix the bent by ballooning to complete the procedure.Patient outcome: there have been no adverse effcts to the patient reported.

• 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
• 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 Key: 7395044
• MDR Text Key: 104250285
• Report Number: 3002808486-2018-00398
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002449715
• UDI-Public: (01)10827002449715(17)210125(10)E3681060
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2021
• Device Catalogue Number: ZTA-P-42-225-W1
• Device Lot Number: E3681060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/16/2018
• Device Age: 1 MO
• Date Manufacturer Received: 06/15/2018
• Date Device Manufactured: 01/25/2018
• 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
• Patient Outcome(s): Life Threatening