MAUDE Adverse Event Report: COOK INC ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problems Other (for use when an appropriate patient code cannot be identified) (2200); No Code Available (3191)

Event Type  Injury  

Event Description

The physician suspects a type 3 endoleak in the main body anterior of the (b)(6) male pt.Additional info has been requested but it has not been provided at the time of this report.

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Manufacturer Narrative

Lot # not provided by reporter.Expiration date unknown as lot # is unknown.Udi # unknown as lot # is unknown.Actual age of device is unknown as date of event was not provided.(b)(4).Event evaluation: a review of complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, and quality control (qc) was conducted during the investigation.Very little information was available about the circumstances around this reported event.Detailed medical imaging was provided by the customer and reviewed by a qualified physician (m.D.).The findings of the report include confirmation of an endoleak.In the impression section of the medical imaging review report states that, "the endoleak represents either a type 3 endoleak through the anterior mainbody mid second sealing stent fabric or a growing type1a endoleak given the sealing zone expansion beyond the mainbody design diameter." and that "the left limb sealing stent seal zone expansion raises the possibility that this patents arteries are more prone to expansion than usual." the device history record was reviewed for potential quality issues and none were found.The zenith device has completed design control requirements demonstrating that the device meets the predetermined requirements and that the requirements meet the needs of the user.There is no evidence to suggest that the product was not manufactured to the correct specifications.The ifu provides instructions for use, contraindications, warnings and precautions regarding the appropriate method of use.Specifically, it states "additional endovascular interventions or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing an enlarging aneurysm, unacceptable decrease in fixation length (vessel and component overlap) and/or endoleak.An increase in aneurysm size and/or persistent endoleak or migration may lead to aneurysm rupture.Patients experiencing reduced blood flow through the graft limb and/or leaks may be required to undergo secondary interventions or surgical procedures." the tffb main body grafts are 100% qc inspected to confirm correct stents have been used and have been placed correctly on the graft and to confirm that the entire graft has no damage, foreign matter, frays, or holes except for suture entry and exit points.Without additional information, no conclusion can be drawn about the root cause for this complaint.The appropriate internal personnel will be notified and we will continue to monitor for similar complaints.

Event Description

The physician suspects a type 3 endoleak in the main body anterior of the (b)(6) male patient.Additional information has been requested but it has not been provided.

• Brand Name: ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4792493
• MDR Text Key: 5876730
• Report Number: 1820334-2015-00302
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TFFB-26-125-ZT
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 5 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/21/2015
• Initial Date FDA Received: 05/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2010
• 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): Other
• Patient Age: 66 YR