MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-03-17 for PIPELINE manufactured by Micro Therapeutics, Inc. Dba Ev3.
[184170430]
Since the devices were 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 Sequence No: 1, Text Type: N, H10
[184170431]
Clin neuroradiol. 2019 dec;29(4):725-731. Doi: 10. 1007/s00062-018-0723-z. Epub 2018 aug 30. ? Treatment of unruptured, tandem aneurysms of the ica with a single flow diverter? P. Bhogal, j. Chudyk, c. Bleise, i. Lylyk, n. Perez, h. Henkes, p. Lylyk medtronic received the following report through literature review: there were three technical complications with incomplete opening of the devices requiring balloon angioplasty at the end of the procedure, which occurred with the pipeline. There were three clinical complications. In one patient there was a large puncture site hematoma and one patient suffered from epistaxis secondary to the anti-platelet medication. In one case the patient stopped taking the anti-platelet medication and this resulted in occlusion of the ica and a large hemispheric infarction and death. There was no allegation to what device was used to treat these three patients. A total of 69 patients (62 female, 89. 8%) with average age 55? 14. 8 years were identified. In total there were 169 aneurysms and the majority of patients (n= 47, 68. 1%) had only 2 tandem aneurysms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029214-2020-00246 |
| MDR Report Key | 9844977 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2018-03-26 |
| Date Mfgr Received | 2020-03-05 |
| Date Added to Maude | 2020-03-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MGR. KATCHA TAYLOR |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9496801345 |
| Manufacturer G1 | MICRO THERAPEUTICS, INC. DBA EV3 |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PIPELINE |
| Generic Name | INTRACRANIAL ANEURYSM FLOW DIVERTER |
| Product Code | OUT |
| Date Received | 2020-03-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICRO THERAPEUTICS, INC. DBA EV3 |
| Manufacturer Address | 9775 TOLEDO WAY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-17 |