MAUDE Adverse Event Report: COOK, INC. ZENITH RENU AAA ANCILLARY GRAFT MAIN BODY EXTENSION; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number N/A

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Surgical procedure, additional (2564); No Code Available (3191)

Event Date 06/29/2015

Event Type  Injury  

Event Description

An (b)(6) male patient underwent a procedure for a type iii endoleak.The physician pulled the trigger wire and the top cap did not deploy.The physician converted to an open procedure and had to explant the partially deployed graft.The procedure was completed by the physician using a regular graft.Patient currently still in hospital in recovery.

Manufacturer Narrative

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

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, trends and instructions for use (ifu) was conducted during the investigation.The device is shipped with an ifu listing the indications for use, contraindications, warnings, precautions, and the correct deployment procedure: the ifu also recommends using a cook lunderquist extra stiff wire guide (les).Use of this specific wire guide could prevent/reduce this failure mode from occurring and/or reduce the probability of the worst case severity occurring.A lunderquist wire was used.The image of the explanted graft was reviewed, no notable observations regarding the quality of the product were noted.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of the lot history shows no nonconforming events which could contribute to this failure mode.In this case, the top cap was difficult to deploy, resulting in the need for open repair.The sales rep arrived during the deployment and saw that the doctor had removed both trigger wires at the same time, which is against the ifu and proper event sequence.If both are removed simultaneously, there is nothing to hold the graft in place while removing the top cap, making it very difficult to finish the procedure.Therefore, the root cause of this complaint is user error through not following the ifu.During the deployment the doctor had removed both trigger wires at the same time, which is against the ifu and proper event sequence.If both are removed simultaneously, there is nothing to hold the graft in place while removing the top cap, making it very difficult to finish the procedure.Based on the information provided, no product returned and the results of our investigation, the root cause of this complaint is user error through not following the ifu.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

Event Description

An (b)(6) year old male patient underwent a procedure for a type iii endoleak.The physician pulled the trigger wire and the top cap did not deploy.The physician converted to an open procedure and had to explant the partially deployed graft.The procedure was completed by the physician using a regular graft.Patient currently still in hospital in recovery.

• Brand Name: ZENITH RENU AAA ANCILLARY GRAFT MAIN BODY EXTENSION
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4919537
• MDR Text Key: 15312198
• Report Number: 1820334-2015-00424
• 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: Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/29/2015

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 Expiration Date: 07/01/2016
• Device Model Number: N/A
• Device Catalogue Number: RX1-36-54-ZT
• Device Lot Number: 4398104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/29/2015
• Device Age: 2 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/01/2015
• Initial Date FDA Received: 07/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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: 85 YR