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-36-161

Device Problems Difficult to Insert (1316); Difficult to Remove (1528); Appropriate Term/Code Not Available (3191)

Patient Problems Tissue Damage (2104); Device Embedded In Tissue or Plaque (3165)

Event Date 08/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Name and address for importer site: (b)(4).Pma 510(k): similar to device under 510(k) p140016.(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: "emergency tevar in middle of night, tortuous and diseased iliacs.Were unable to measure diameter of iliacs prior to case.Attempted to insert delivery system on right but could not advance sheath.Angioplasty to left side and then managed to get sheath up on this side.Graft deployed successfully without any problems." angioplasty was performed in order to try and aid removal but it was still stuck within the artery.They continued to use force to remove and the external part of the sheath came out.However some internal parts of the sheath remained within the iliacs.They were eventually pulled out but damage was caused to the artery.Patent outcome: the patient did require additional procedures due to this occurrence."patch repair to femoral artery.Continuing to monitor left leg circulation".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: according to imaging review there is severe calcified disease of the abdominal aorta and access vessels with very small caliber of bilateral external iliac arteries (eia).Despite balloon angioplasty of bilateral access vessels, the stent graft device could not be passed via the right side.It was successfully passed via the left side but met significant resistance on attempt to remove it after device deployment.Initially, the sheath broke with a long segment of the tip remaining inside the eia.This was then removed successfully but, per the report, ¿damage was caused to the artery.¿ the sheath removal was attempted without the dilator in place, which likely made it more difficult.However, the likely reason for the complication is inadequate access vessels for device delivery.The left eia measures 4.32 mm on angiographic images with severe calcified disease.The 36 mm zenith alpha thoracic device has a sheath outer diameter of 7.1 mm.The access vessels are outside of ifu for this device.No evidence to suggest that the product was not manufactured according to specifications.Cook medical will continue to monitor for similar events.

• 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 Contact: thomas hessner kirk ; sandet 6; bjaeverskov DK-46-32 ; DA DK-4632 ; 56868686
• MDR Report Key: 6841189
• MDR Text Key: 84621139
• Report Number: 3002808486-2017-01741
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002347004
• UDI-Public: (01)10827002347004(17)190728(10)E3476962
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 08/16/2017

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: ZTA-P-36-161
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/16/2017
• Device Age: 13 MO
• Initial Date Manufacturer Received: 08/16/2017
• Initial Date FDA Received: 09/05/2017
• Supplement Dates Manufacturer Received: 11/24/2017
• Supplement Dates FDA Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2016
• 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