MAUDE Adverse Event Report: WILLIAM A. COOK AUSTRALIA, PTY LTD ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number G32542

Device Problems Fracture (1260); Difficult to Remove (1528); Failure to Align (2522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/07/2017

Event Type  malfunction  

Event Description

Upon removing the shipping protector, it was difficult to remove.An attempt was made to pull off the protector with an instrument (ex.Forcep).The two ends were cut and the protector was peeled away from the device.As the device was difficult to remove from its protector, it was viewed under xray and struts looked to be misaligned.Upon unsheathing fenestrated graft on back table, stent strut configuration for a 10 mm in diameter large fenestration was noticed to be in an alternative configuration than what was noted in images that came with unopened graft.Upon closer examination, strut was found to be completely fractured apart.Case was canceled as a result of concern of structural integrity and patient safety.

Event Description

Upon removing the shipping protector, it was difficult to remove.An attempt was made to pull off the protector with an instrument (ex.Forcep).The two ends were cut and the protector was peeled away from the device.As the device was difficult to remove from its protector, it was viewed under xray and struts looked to be misaligned.Upon unsheathing fenestrated graft on back table, stent strut configuration for a 10mm in diameter large fenestration was noticed to be in an alternative configuration than what was noted in images that came with unopened graft.Upon closer examination, strut was found to be completely fractured apart.Case was canceled as a result of concern of structural integrity and patient safety.09 august 17 update after additional information was received on the 20 july 17: question: can you confirm that during the inspection prior to use, if there was any evidence of damage to the shipping box and device? during evaluation of the returned device, it was observed that there was a bend on one side of the shipping box.Answer: no, there was nothing wrong with the box.The bend in the side of the box was from me bending it after the graft was already out to get the sticker off the side of the box.

Manufacturer Narrative

The complaint device was returned for evaluation: the graft was unsheathed and attached by the topcap, proximal and distal attachments.The stent wire passing the large fenestration was fractured at the stent point next to the fenestration (on the left renal side).The stent wire passing the large fenestration had scratches on the surface, and was bent at multiple places.The scratches and deformation observed are consistent with the use of hand tools on the wire.The bend/deformation location in the struts do not appear to be random, the opposing struts located in the large fenestration are bent in approximately the same locations and mirror each other.The fracture seems a ductile failure (cup and cone shaped fracture surfaces) typically associated with significant plastic deformation, in this case, appears to have been caused by excessive bending.The large fenestration is not a strut free fenestration.Additional information was received on the 08 aug 17: can you confirm if the device was grabbed around the sheath while trying to remove the shipping protector? no, it was grabbed by the grey inner cannula.Were any tools to handle the stent wire used during this inspection? no.The work order record for lot ac993453 was reviewed and appeared complete and correct.The photographs taken of the graft during manufacturing were reviewed.The graft appears to be manufactured as per the fenestration layout and the charts approved.The struts passing through the large fenestration are straight, with no evidence of bending and fracture of the stent point.Manufacturing instruction lists the following controls for limiting risks associated with damage/fracture: 100% check to confirm stent wires are not bent or scratched.Procedure for bending stent struts around fenestrations or scallops is specified.Process for symmetrically compressing stents specified.Peel-away sheaths used to aid in compressing stents symmetrically.100% check of sheath lumpiness and stress marks.The ifu supplied with the device states: "inspect the device and packaging to verify that no damage has occurred as a result of shipping.Do not use this device if damage has occurred or if the sterilization barrier has been damaged or broken.If damage has occurred, do not use the product and return to your cook representative or your nearest cook office.Prior to use, verify correct devices (quantity and size) have been supplied for the patient by matching the device to the order prescribed by the physician for that particular patient." "before insertion, position proximal body delivery system on patient¿s abdomen under fluoroscopy to assist with orientation and positioning.Rotate to a position where the anterior markers are situated in the most anterior (12:00 o¿clock) position.The sidearm of the hemostatic valve may serve as an external reference to the fenestration(s) and/or scallop(s), anterior and posterior markers and body side markers." the damage observed on the returned item is not consistent with that expected from normal loading or deployment operations.The presence of scratches on the surface suggests the use of a hand tool such as forceps or pliers to intentionally bend the struts of the stent.The deformation locations are precise and mirrored between the opposing struts, which suggest the deliberate application of force in the given locations.The deformation does not appear to be random.Therefore, the most likely explanation for the stent fracture is that it has occurred as a direct result of the application of force exceeding the tensile strength of the material to the finished product by an operator in order to modify the stent configuration or during preparation of the device where difficulty was experienced with the shipping protector.

Event Description

Upon removing the shipping protector, it was difficult to remove.An attempt was made to pull off the protector with an instrument (ex.Forcep).The two ends were cut and the protector was peeled away from the device.As the device was difficult to remove from its protector, it was viewed under xray and struts looked to be misaligned.Upon unsheathing fenestrated graft on back table, stent strut configuration for a 10mm in diameter large fenestration was noticed to be in an alternative configuration than what was noted in images that came with unopened graft.Upon closer examination, strut was found to be completely fractured apart.Case was canceled as a result of concern of structural integrity and patient safety.09 august 17 update after additional information was received on the 20 july 17: question: can you confirm that during the inspection prior to use, if there was any evidence of damage to the shipping box and device? during evaluation of the returned device, it was observed that there was a bend on one side of the shipping box.Answer: no, there was nothing wrong with the box.The bend in the side of the box was from me bending it after the graft was already out to get the sticker off the side of the box.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane QLD 4 113; AS QLD 4113
• Manufacturer Contact: nicolas bidaud ; 95 brandl street; eight mile plains; brisbane, qld 4113 ; AU 4113 ; 738411188
• MDR Report Key: 6672311
• MDR Text Key: 78812424
• Report Number: 9680654-2017-00015
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002325422
• UDI-Public: (01)10827002325422(17)200412(10)AC993453
• 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: distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/04/2017

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
• Device Operator: No Information
• Device Model Number: G32542
• Device Catalogue Number: ZFEN-P-2-28-124-R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2017
• Initial Date FDA Received: 06/27/2017
• Supplement Dates Manufacturer Received: 06/07/2017; 06/07/2017
• Supplement Dates FDA Received: 08/08/2017; 09/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1