N
Patient 1
PMA/510(K) #: K160593. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
MAUDE MDR 8354567
- MDR report key
- 8354567
- Report number
- 1820334-2019-00329
- Event key
- 0
- Event type
- 3
- Date received
- 2019-02-20
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. LARRY POOL
- Address
- 750 DANIELS WAY BLOOMINGTON IN 47404 US
- Phone
- 812-812-8123
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-02-20 | 0 | 1. R |
Event Narratives#
D
Patient 1
AN ADVERSE EVENT REPORT WAS IDENTIFIED IN THE JOURNAL ARTICLE: A. FRECH ET AL., SURGICAL PFO OCCLUDER SYSTEM RETRIEVAL; CASE REPORT, VASA (2017), VOLUME 46(4), PP 310?312. THIS INFORMATION WAS RETRIEVED FROM: HTTPS://DOI.ORG/10.1024/0301-1526/A000620. THE CASE REPORT STATES, ?PERCUTANEOUS CLOSURE OF A LARGE (8 X 3 MM IN 3-DIMENSIONAL TRANSOESOPHAGEAL ECHOCARDIOGRAPHY; (SEE FIGURE 1) PFO WITH A PRONOUNCED ATRIAL SEPTUM ANEURYSM WAS INDICATED IN A (B)(6) MALE WITH A HISTORY OF PARADOXICAL EMBOLISM LEADING TO STROKE CAUSED BY A LOWER LEG DEEP VENOUS THROMBOSIS. A FIGULLA FLEX II DOUBLE DISK 25 MM PFO OCCLUDER SYSTEM (OCCLUTECH? GMBH, JENA, GERMANY) WAS SUCCESSFULLY PLACED (NORMAL WIGGLE TEST, REGULAR RIGHT ATRIAL ANGIOGRAM BEFORE DEVICE RELEASE) WITHOUT ANY IMMEDIATE PERIPROCEDURAL COMPLICATIONS (SEE FIGURE 2). TRANSOESOPHAGEAL ECHOCARDIOGRAM ON THE FIRST POST-PROCEDURAL DAY SURPRISINGLY SHOWED A DISLOCATED OCCLUDER SYSTEM WHICH WAS CONSECUTIVELY DETECTED BY COMPUTED TOMOGRAPHY, LOCATED IN THE ABDOMINAL AORTA CLOSE TO THE ORIGIN OF THE MESENTERIC VESSELS (SEE FIGURE 3). THE PASSAGE OF THE DEVICE THROUGH THE LEFT HEART TO THE ABDOMINAL AORTA OCCURRED WITHOUT SYMPTOMS REPORTED BY THE PATIENT. INTERVENTIONAL RETRIEVAL THROUGH THE RIGHT FEMORAL ARTERY WAS INTENDED, USING AN INDY OTW VASCULAR RETRIEVER (COOK MEDICAL EUROPE LTD. LIMERICK, IRELAND). IT WAS POSSIBLE TO SNARE THE OCCLUDER SYSTEM AND TO PULL IT DOWN FROM THE PROXIMAL ABDOMINAL AORTA TO THE LEVEL OF THE AORTIC BIFURCATION (SEE FIGURE 4). AT THIS POSITION THE OCCLUDER SYSTEM WAS TRAPPED AT THE AORTIC WALL AND FINALLY COULD NOT BE RETRIEVED THROUGH A SHEATH. THEREFORE, AN OPEN SURGICAL RETRIEVAL WAS INDICATED, WHICH WAS SUCCESSFULLY ACHIEVED BY LAPAROTOMY AND LATERAL ARTERIOTOMY OF THE INFRARENAL AORTA (SEE FIGURE 5). THE POSTOPERATIVE COURSE WAS UNEVENTFUL AND THE PATIENT WAS DISMISSED FROM THE HOSPITAL ON THE SEVENTH POSTOPERATIVE DAY. READMISSION FOR SURGICAL CLOSURE OF THE PFO AND RESECTION OF THE ATRIAL SEPTUM ANEURYSM WAS PLANNED AT DISCHARGE?. (A. FRECH ET AL., 2017). ?WE REPORT A VERY RARE COMPLICATION OF CLINICALLY ASYMPTOMATIC DEVICE EMBOLIZATION TO THE ABDOMINAL AORTA. IN PREVIOUSLY PUBLISHED CASES OF PFO OCCLUDER DEVICE EMBOLIZATION, DEVICE RETRIEVAL COULD BE ACHIEVED THROUGH PERCUTANEOUS INTERVENTION [4, 5, 6]. IN OUR CASE, ENDOVASCULAR RETRIEVAL OF THE DISLOCATED OCCLUDER SYSTEM WAS UNSUCCESSFUL BECAUSE OF TRAPPING OF THE SYSTEM NEAR THE AORTIC BIFURCATION. THEREFORE OPEN SURGERY WAS INDICATED. USING A STANDARDISED TRANSPERITONEAL APPROACH, THE OCCLUDER DEVICE WAS REMOVED VIA ARTERIOTOMY". (A. FRECH ET AL., 2017).