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

Catalog Number	ESBE-26-58
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
On (b)(6) 2017, a (b)(6) female patient underwent a procedure for endovascular aneurysm repair (evar).This patient was not a anatomically suitable for the procedure since severe curvature was observed from the proximal neck to the aneurysm, however, the physician opted to perform the evar due to the risk associated with an open abdominal surgery exacerbated by the patient's age.An access route larger than 7.7mm was made and it was noted that mild calcification existed in the common iliac artery (cia) and the external iliac artery (eia).The procedure was planned according to an anticipated proximal type i endoleak due to severe tortuosity from the proximal neck to the aneurysm and a body extension placement was planned as additional treatment if necessary.First, evar with main body, ipsilateral and contralateral iliac legs with balloon touch was completed.Angiography confirmed a proximal type i endoleak as predicted.The physician performed body extension placement as planned.A zenith aaa endovascular graft aaa ancillary component main body extension was selected and inserted into the patient.However, the physician encountered strong resistance at the puncture site, so he removed the delivery system and noted that the sheath tip was damaged (deformed).The physician was not aware of sheath damage prior to procedure, therefore, cannot say with certainty when the damage to the sheath occurred.A second device had been prepared and it was inserted without resistance and advanced to the target site.The type 1 endoleak was not resolved with the one device.Two other extensions were additionally placed with a balloon touch-up.The type 1 endoleak was resolved and the procedure was successfully completed.Additionally, it was noted that the patient has recovered from this procedure.
Additional Manufacturer Narrative
Corrected data: correction of date rec'd by mfr on initial report to 02/16/2017.A review of the complaint history, device history record, instructions for use (ifu), trends, quality control, and an image review was conducted during the investigation.There is no evidence to suggest the product was not made to specifications.Review of the device history record shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Instructions are in place to verify that the device is manufactured to specification.The device is shipped with instructions for use (ifu) listing the indications for use, contraindications, warnings and precautions, and the correct deployment procedure.Product was not returned for evaluation.However, the customer did provide photographs of the complaint device which confirm the damage to the sheath tip.The damage to the sheath tip could have occurred due to advancement into a tortuous or calcified artery.The event description states that there was mild calcification in the cia and eia, which could have caused the sheath tip damage if the delivery system was advanced that far into the body.An encounter between the proximal part of the sheath and calcified / tortuous vessels could create the strong resistance cited in the complaint, leading to the sheath tip damage.In addition, scarring around the insertion site could have resulted in the device failure.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• Brand Name: ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6412877
• Report Number: 1820334-2017-00401
• Device Sequence Number: 31345
• Product Code: MIH
• UDI-Device Identifier: 10827002427850
• UDI-Public: (01)10827002427850(17)181117(10)7434754
• Combination Product (Y/N): N
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2017

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ESBE-26-58
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2017
• Supplement Report FDA Received Date: 06/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1