| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PIPELINE | INTRACRANIAL ANEURYSM FLOW DIVERTER | MICRO THERAPEUTICS, INC. DBA EV3 | OUT | * | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-18 | 0 | 1. D; 2. R |
Patient 1
HOWEVER, SINCE THE DEVICE WAS NOT RETURNED, WE ARE UNABLE TO PERFORM FURTHER ROOT CAUSE ANALYSIS AND THE EXACT CAUSE OF THE REPORTED EVENT IS UNKNOWN. ALL DEVICES ARE 100% TESTED AND ALL PRODUCTS ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. NO CORRECTIVE ACTION. MONITORING AND TRENDING THIS TYPE OF EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Patient 1
INTERV NEURORADIOL. 2019 AUG;25(4):407-413. DOI: 10.1177/1591019918824003. EPUB 2019 FEB 25. ?TREATMENT OF POSTERIOR INFERIOR CEREBELLAR ARTERY ANEURYSMS USING FLOW-DIVERTER STENTS: A SINGLE-CENTER EXPERIENCE? SU?KRU? OG?UZ AND HASAN DINC. MEDTRONIC RECEIVED THE FOLLOWING REPORT THROUGH LITERATURE REVIEW: EIGHT PATIENTS WITH EIGHT ANEURYSMS RELATED TO THE PICA WERE TREATED WITH A FLOW-DIVERTER STENT BETWEEN SEPTEMBER 2013 AND MAY 2017. HALF OF THE PATIENTS WERE FEMALE, AND THE MEAN AGE WAS 55 YEARS (RANGE, 34 TO 71). PROCEDURAL SUCCESS WAS 100% (8/8), AND THERE WERE NO ISCHEMIC COMPLICATIONS. IN TWO CASES THE PROXIMAL PART OF THE STENT SHORTENED AND MIGRATED. CASE #3: IN ONE PATIENT, WE DEPLOYED A SECOND STENT TELESCOPICALLY. THIS PATIENT PRESENTED WITH SAH AND WAS TREATED IN THE ACUTE PERIOD BUT DIED BECAUSE OF REBLEEDING TWO WEEKS AFTER THE PROCEDURE (MRS, 6). CASE #4: A (B)(6)-YEAR-OLD MALE PATIENT WHO HAD A RIGHT VERTEBRAL ARTERY V4 SEGMENT INCIDENTAL FUSIFORM ANEURYSM. DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) IMAGE DEMONSTRATING A RIGHT VERTEBRAL ARTERY V4 SEGMENT FUSIFORM ANEURYSM INVOLVING THE RIGHT POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA) ORIGIN. THE ROAD-MAP IMAGE SHOWS THAT THE STENT WAS DROPPED INTO THE ANEURYSM SAC, WHICH PASSED NEAR THE STENT. FLUOROSCOPIC, DSA AND DYNA COMPUTED TOMOGRAPHY IMAGES SHOWING THE FINAL STATE; THE SECOND STENT AND THE FIRST STENT WERE JAILED IN THE ANEURYSM. (F) AT THE SIX-MONTH FOLLOW-UP DSA, THE ANEURYSM WAS TOTALLY OCCLUDED, AND THE PICA WAS PATENT. FOUR PATIENTS PRESENTED WITH SAH, AND THREE OF THEM (CASE NOS. 2, 3 AND 8) DEVELOPED IMPAIRMENT OF CONSCIOUSNESS SECONDARY TO ACUTE HYDROCEPHALUS. LUMBAR DRAINAGE WAS PERFORMED AT REGULAR INTERVALS CONSIDERING THE CHANGES IN THE PATIENT?S STATE OF CONSCIOUSNESS. HYDROCEPHALUS DID NOT PERSIST IN THE CHRONIC PERIOD IN ANY PATIENT, AND EXTERNAL VENTRICULAR DRAINAGE WAS NOT NECESSARY. OTHER THAN CASE #3, ALL THE PATIENT MRS SCORES WERE ZERO AT DISCHARGE AND AT THE CLINICAL FOLLOW-UP PERIOD.