MAUDE Adverse Event Report: COOK INC ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number N/A

Device Problem Displacement (1180)

Patient Problem Surgical procedure, additional (2564)

Event Date 03/11/2015

Event Type  Injury  

Event Description

During an endovascular repair of aaa procedure on a female pt, the limb length was chosen to extend down to just above the zenith 16mm x 90mm internal iliac leg graft.When the limb was inserted and matched the dot to tick, it was noted that the limb appeared to finish a lot shorter than expected.It was though the limb length must have been compressed in the delivery system.The limb was deployed half way and then a doctor put a bit of tension on the graft to lengthen the graft to where it was to finish.The placement looked good.During the insertion of the ipsilateral limb, it was noted that the contralateral limb had slipped down and now only had 1/2 a sealing stent in the main body.A calibrated catheter was put inside the contralateral limb and showed from the dot to the bottom of the contralateral limb was only 65 from a 90 length limb dot to distal end.The physician expected approx 84 of working length.A zenith graft 13mm x 56 mm was put in as a bridging stent to secure to limb to the main body on the contralateral side.A coda balloon was used to secure all sealing stents.End of case imaging was satisfactory.Apart from the successfully deployed graft, no part of the device remained inside the pt.The pt did not require an add'l procedure due to this occurrence; however, an additional device did have to be deployed during the procedure due to this event.No adverse effects to the pt were reported due to this occurrence.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).Event evaluation: a review of complaint history, instructions for use (ifu), quality control, and trends was conducted during the investigation.No product was returned to assist with this investigation; however, imaging was returned electronically and forwarded for expert review.This product line has addressed all design control requirements and shown the device has met the predetermined requirements and that those requirements meet the needs of the user.Each device is sent with an ifu which describes the indications for use, warnings, precautions, sizing instructions, and the proper deployment sequence.Specific to this case, the ifu states: "inadequate overlap of the zenith spiral-a aaa iliac leg may result in increased risk fo migration of the stent graft.Incorrect deployment or migration of the endoprosthesis may require surgical intervention." "avoid damaging the graft or disturbing the graft positioning after placement in the event reinstrumentation (secondary intervention) of the graft is necessary." the returned imaging was forwarded for expert review.The reviewer assessed: "the complaint report states that only 65mm of working length was measured by marker catheter after ipsilateral stent deployment.Although this imaging is not provided, imaging performed after bridging stent deployment confirmed this.However, the contralateral gate superior displacement and the contralateral limb inferior displacement show that this shortening was not the product of slippage of a shorter than specified stent stretched to its desired length, but the result of inadvertent limb gate displacement.Even if any stretch was present, the left common iliac origin stenosis would have fixed it in place." lot records were reviewed and no notable concerns regarding product quality were observed.There is no evidence to suggest that the device was not manufactured to specification.It was concluded that the failure mode in this case was deployment difficulties.This failure mode was determined based on the provided event description and expert review of the provided imaging.We will continue to monitor for similar complaints.

Event Description

During an endovascular repair of aaa procedure on a female patient, the limb length was chosen to extend down to just above the zenith 16mm x 90mm internal iliac leg graft.When the limb was inserted and matched the dot to tick, it was noted that the limb appeared to finish a lot shorter than expected.It was thought the limb length must have been compressed in the delivery system.The limb was deployed half way and then the doctor put a bit of tension on the graft to lengthen the graft to where it was to finish.The placement looked good.During the insertion of the ipsilateral limb, it was noted that the contralateral limb had slipped down and now only had 1/2 a sealing stent in the main body.A calibrated catheter was put inside the contralateral limb and showed from the dot to the bottom of the contralateral limb was only 65 from a 90 length limb dot to distal end.The physician expected approximately 84 of working length.A zenith graft 13mm x 56 mm was put in as a bridging stent to secure to limb to the main body on the contralateral side.A coda balloon was used to secure all sealing stents.End of case imaging was satisfactory.Apart from the successfully deployed graft, no part of the device remained inside the patient.The patient did not require an additional procedure due to this occurrence; however, an additional device did have to be deployed during the procedure due to this event.No adverse effects to the patient were reported due to this occurrence.

• Brand Name: ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
• 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: 4707905
• MDR Text Key: 5665050
• Report Number: 1820334-2015-00235
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/16/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2017
• Device Model Number: N/A
• Device Catalogue Number: ZSLE-16-90-ZT
• Device Lot Number: 5524191
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/11/2015
• Device Age: 3 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/16/2015
• Initial Date FDA Received: 04/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2014
• 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