MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL COMPONENTS; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number ZTA-D-28-160

Device Problems Break (1069); Failure to Align (2522); Activation, Positioning or Separation Problem (2906)

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

Event Date 10/27/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Description of event according to initial reporter: it was not possible to release the wire in the normal way.Problem experienced with a distal zta, had to open the system and remove the wires, but the graft still was stuck a bit.Managed to remove everything but graft dropped a bit and distal stent broken.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Similar to device under 510(k): p140016.(b)(4).Summary of investigational findings: product examination showed a small amount of fraying and a tiny hole at the sheath tip, suggesting deployment issues.The length of the parts that can be responsible for the reported event was measured and nothing indicates that the device was not manufactured according to specification.In connection with this complaint a visit at the hospital was arranged to have a dialogue with the user about the reported event and to go through the deployment sequence in details.The dialogue suggested uncertainty about whether the doctor had pulled the sheath sufficient back during distal bare stent release.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: it was not possible to release the wire in the normal way.Problem experienced with a distal zta, had to open the system and remove the wires, but the graft still was stuck a bit.Managed to remove everything but graft dropped a bit and distal stent broken.Patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: product examination showed a small amount of fraying and a tiny hole at the sheath tip, suggesting deployment issues.The length of the parts that can be responsible for the reported event was measured and nothing indicates that the device was not manufactured according to specification.In connection with this complaint a visit at the hospital was arranged to have a dialogue with the user about the reported event and to go through the deployment sequence in details.The dialogue suggested uncertainty about whether the doctor had pulled the sheath sufficient back during distal bare stent release.Furthermore, it is assumed that forceful handling of the device during release of the bare stent could explain the stent fracture.Cook medical will continue to monitor for similar events.

• Brand Name: ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL COMPONENTS
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• 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 Key: 6108843
• MDR Text Key: 60086803
• Report Number: 3002808486-2016-01409
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002346021
• UDI-Public: (01)10827002346021(17)180408(10)E3318723
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P140016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2016

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZTA-D-28-160
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/27/2016
• Device Age: 16 MO
• Initial Date Manufacturer Received: 10/27/2016
• Initial Date FDA Received: 11/17/2016
• Supplement Dates Manufacturer Received: Not provided; 10/27/2016
• Supplement Dates FDA Received: 04/20/2017; 11/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2015
• 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): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 67