MAUDE Adverse Event Report: LOMBARD MEDICAL LTD. AORFIX AAA FLEXIBLE STENT GRAFT; ENDOVASCULAR STENT GRAFT

Model Number	SG-HBB-24-96-80-18
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Aneurysm (1708); Occlusion (1984)
Date of Event	07/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional plug-in leg information: model no.Sg-hbl-81-18-a13-20, lot no.Bl53688-1, manufacture date.07 oct 2014, expiry date.06 oct 2016.A full review of the device history record for these devices has been carried out with no anomalies identified; product was manufactured and released for sale in accordance with specifications.There is no information to suggest that the devices have not met the final release criteria.From a review of the patient's anatomy, both iliacs are severely tortuous and the proximal neck is highly angulated (alpha~ 77, beta~ 82).It is most likely that the physician encountered significant resistance inserting the contralateral limb in the external iliac due to the extreme tortuosity.The buckling of the nosecone due to it being unsupported by the lunderquist wire, led to the proximal end of the main body stent graft being pushed up and occluding the renal arteries.There is no information to suggest a device malfunction.
Event or Problem Description
Evar was performed (b)(6) 2016.Event: main body aorfix graft proximal migration (open repair conversion).Contralateral limb was inserted with significant resistance from external iliac.Left ipsilateral leg was constrained 3cm past gate.Surgeon advanced then relaxed.This was repeated with some success.It was noted the contralateral lunderquist wire at the back table had greatly retracted.Surgeon imaged proximal to see wire position and noted floppy end of wire was now in the nosecone of delivery catheter.This resulted in nosecone buckling in neck angle and pushing graft proximally above the left renal artery.Post angio run of deployed main body and contralateral leg, imaging revealed main body graft had migrated above renal arteries leading physician to opt for open conversion and resection of implanted graft(s).

• Brand Name: AORFIX AAA FLEXIBLE STENT GRAFT
• Common Device Name: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): LOMBARD MEDICAL LTD.; 4 trident park; didcot, oxfordshire OX11 7HJ; UK OX11 7HJ
• MDR Report Key: 5871152
• Report Number: 3004753364-2016-00024
• Device Sequence Number: 19174119
• Product Code: MIH
• UDI-Device Identifier: 05055715607063
• UDI-Public: (01)05055715607063(17)170429(10)CU61737-1
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P110032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2016

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
• Operator of Device: Physician
• Device Expiration Date: 04/29/2017
• Device Model Number: SG-HBB-24-96-80-18
• Device Lot Number: CU61737-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2016
• Initial Report FDA Received Date: 08/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 70 YR