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

Model Number	SG-HBB-24-96-80-20
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Aneurysm (1708); Occlusion (1984); Thrombus (2101)
Date of Event	07/31/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A full review of the device history record for this device 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 device has not met the final release criteria.The physician has stated that the occlusion of the internal iliac artery was not identified during the original procedure and would have placed a bare stent at that time if detected.The diameter of the left cia was 15-16 mm, however the diameter right above the iia bifurcation was 11 mm.A contralateral limb of 18mm in diameter was implanted which was therefore oversized by 39%.The instructions for use recommends oversizing no more than 20%.It is likely that the occlusion was caused by the inappropriate contralateral limb diameter size of 18 mm against the narrow access vessel diameter.
Event or Problem Description
Original evar was performed (b)(6) 2016.A main body was inserted by the right approach in accordance to the ifu.The physician successfully completed the procedure with no issues.When the patient was followed up, the abi (ankle brachial index) value became worse.The physician confirmed that thrombus was present inside the left contralateral limb.The angiography revealed the internal iliac artery however the proximal portion was occluded.The physician aspirated the thrombus inside the contralateral socket with a catheter shaped vs then inflated the balloon catheter.The internal iliac artery remained occluded and the physician tried to resolve by attempting to push up the distal contralateral limb with a coda balloon.In addition it was confirmed that the external iliac artery was stenosed, this was resolved and the abi value was recovered.The procedure was completed by placing an express (vascular) ld10-37 in the distal portion of the contralateral limb.

• 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: 5972522
• Report Number: 3004753364-2016-00029
• Device Sequence Number: 16241014
• Product Code: MIH
• UDI-Device Identifier: 05055715607070
• UDI-Public: (01)05055715607070(17)170715(10)CP65182-1
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2016

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: 07/15/2017
• Device Model Number: SG-HBB-24-96-80-20
• Device Lot Number: CP65182-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2016
• Initial Report FDA Received Date: 09/23/2016
• 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; Required Intervention
• Patient Age: 82 YR