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

Model Number	SG-HBB-31-111-80-16
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Aneurysm (1708)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It has not been possible to investigate this issue.The explanted stent graft has been discarded by the hospital therefore is not being returned for inspection.Scans/images of the procedure have been requested but these have not yet received.: device disposed of by hospital.
Event or Problem Description
Event: type iiib endoleak identified during re-intervention performed for enlarged aneurysm / explant original evar procedure was performed on (b)(6) 2016.The procedure was completed with a type 4 endoleak remaining.On (b)(6) 2017 (9 months post procedure), follow-up scans confirmed an enlarged aneurysm.A re-intervention was performed to implant a new vascular prosthesis.On removal of the implant, it was identified that there was a hole/tear in the graft (type 3b endoleak).

• Brand Name: AORFIX AAA FLEXIBLE STENT GRAFT
• Common Device Name: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): LOMBARD MEDICAL LTD.; 4 trident park; didcot, OX11 7HJ; UK OX11 7HJ
• MDR Report Key: 6676239
• Report Number: 3004753364-2017-00007
• Device Sequence Number: 81666
• Product Code: MIH
• UDI-Device Identifier: 05055715611558
• UDI-Public: (01)05055715611558(17)180420(10)CP72341-1
• 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
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2017

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: 04/20/2018
• Device Model Number: SG-HBB-31-111-80-16
• Device Lot Number: CP72341-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2017
• Initial Report FDA Received Date: 06/29/2017
• 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: Required Intervention
• Patient Age: 86 YR