GORE® EXCLUDER® AAA ENDOPROSTHESIS
Report
- Report Number
- 2017233-2014-00136
- Event Type
- Injury
- Date Received
- March 15, 2014
- Date of Event
- February 20, 2014
- Report Date
- April 1, 2014
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE IS BEING CONDUCTED. ALSO WERE IMPLANTED: PXC141400/11709969 AND PXL161007/10120618.
THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), GORE RECOMMENDS THAT THE GORE EXCLUDER AAA ENDOPROSTHESIS DIAMETER BE AT LEAST 2 MM LARGER THAN THE AORTIC INNER DIAMETER (10-21% OVERSIZING) AND 1 MM LARGER THAN THE ILIAC INNER DIAMETER (7-25% OVERSIZING). A 23MM DEVICE WAS USED ON THE RIGHT SIDE OF THE GRAFT. PREOPERATIVE IMAGES DATED FROM (B)(6) 2012 SHOWED THAT THE DIAMETERS OF THE PROXIMAL AND MID RIGHT COMMON ILIAC APPEAR TO RANGE FROM 22.4MM TO 26.5MM. ADDITIONALLY, THE IFU STATES THAT THE LENGTH OF THE GORE EXCLUDER AAA ENDOPROSTHESIS SHOULD BE SUFFICIENT TO REACH FROM JUST INFERIOR TO THE MOST DISTAL (LOWEST) MAJOR RENAL ARTERY TO NON-ANEURYSMAL TISSUE IN THE COMMON OR EXTERNAL ILIAC ARTERIES. ALL LENGTHS AND DIAMETERS OF THE DEVICES NECESSARY TO COMPLETE THE PROCEDURE SHOULD BE AVAILABLE TO THE PHYSICIAN, ESPECIALLY WHEN PRE-OPERATIVE CASE PLANNING MEASUREMENTS (TREATMENT DIAMETERS/LENGTHS) ARE NOT CERTAIN. FURTHERMORE, THE GORE EXCLUDER AAA ENDOPROSTHESIS IFU STATES TO PERFORM EXTENDED IMAGING ANGIOGRAPHY TO CONFIRM EXCLUSION OF THE ANEURYSM. ON THE ANGIOGRAPHIC IMAGES DATED (B)(6) 2014, THERE APPEARS TO HAVE BEEN DEVICES IMPLANTED WITHIN THE DISTAL END OF THE DEVICE ON THE RIGHT SIDE THAT EXTENDS INTO THE EXTERNAL ILIAC. AT 11:51:43, THERE APPEARS TO BE FLOW WITHIN BOTH LIMBS OF THE DEVICE. ON THE FINAL ANGIOGRAPHY AT 11:54:57, THERE APPEARS TO BE FLOW WITHIN THE LEFT LIMB AS DETERMINED BY THE PRESENCE OF CONTRAST. UNABLE TO DETERMINE IF THERE IS FLOW WITHIN THE RIGHT SIDE OF THE DEVICE BASED ON THE IMAGES RECEIVED DUE TO LACK OF CONTRAST. THE GORE EXCLUDER AAA ENDOPROSTHESIS IFU STATES THAT ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO COMPONENT MIGRATION, OCCLUSION OF DEVICE OR NATIVE VESSEL AND TRANSIENT ISCHEMIA.
ON (B)(6) 2012, THE PATIENT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT TOLERATED THE INITIAL PROCEDURE. ON (B)(6) 2013, A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS PERFORMED AND SHOWED A GOOD RESULT. ON (B)(6) 2013, A FOLLOW UP CT REVEALED THAT THE COMMON ILIAC ARTERY DILATED AND IDENTIFIED THAT THE RIGHT LIMB (PXC231000/9943417) MIGRATED UPWARDS WHICH CAUSED THE CONTRALATERAL OVERLAP REGION TO KINK AND A 90 DEGREES ANGLE IN THE CONTRALATERAL OVERLAP. ON (B)(6) 2014, THE PHYSICIAN ATTEMPTED TO RELINE THE LIMB AND EXTEND INTO THE EXTERNAL ILIAC WITH GORE EXCLUDER AAA ENDOPROSTHESES (PXC141400/11709969 AND PXL161007/10120618). THE COMPLETE CTA ON (B)(6) 2014 SHOWED THE NICE FLOW AND SEAL. LATER, THE SAME DATE, THE PATIENT HAD AN ISCHAEMIC LEG WITH OCCLUDED FLOW DOWN THAT LIMB AND THE PHYSICIAN PERFORMED A FEM-FEM CROSSOVER. THE PATIENT TOLERATED THE PROCEDURE.
ON (B)(4) 2013, A FOLLOW UP CT REVEALED THAT THE COMMON ILIAC ARTERY HAD DILATED AND IDENTIFIED THAT THE DISTAL PORTION OF THE RIGHT LIMB ((B)(4)) HAD MOVED UPWARDS DUE TO DISEASE PROGRESSION, WHICH CAUSED THE CONTRALATERAL OVERLAP REGION TO KINK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 156044 | GORE® EXCLUDER® AAA ENDOPROSTHESIS | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W.L. GORE & ASSOCIATES | 9943417 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Hospitalization| R |