MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-09-27 for TREVO PROVUE 90184 manufactured by Concentric Medical.
[55731320]
The device is not available.
Patient Sequence No: 1, Text Type: N, H10
[55731321]
Following an infusion of 24 million units of tissue plasminogen activator, recombinant (rtpa), one pass with the subject retrieval device was successfully performed to treat a right m1 middle cerebral artery occlusion. A thrombolysis in cerebral ischemia (tici) score of 3 was achieved after treatment. Further, it was found that the characteristic of the lesion was atherosclerotic. Therefore, following balloon angioplasty, a stent was placed across the stenotic lesion. However, the final tici score was 0. Twi hours post procedure, the patient developed a symptomatic intracranial hemorrhage (sich) in the distal area of the treated vessel. No medical treatment was provided. The physician stated that the cause of the sich was a reperfusion injury.
Patient Sequence No: 1, Text Type: D, B5
[57820125]
Event description was updated. Relevant tests and lab data was added.
Patient Sequence No: 1, Text Type: N, H10
[57820126]
Following an infusion of 24 million units of tissue plasminogen activator, recombinant (rtpa), one pass with the subject retrieval device was successfully performed to treat a right m1 middle cerebral artery occlusion. A thrombolysis in cerebral ischemia (tici) score of 3 was achieved after treatment. Further, it was found that the characteristic of the lesion was atherosclerotic. Therefore, following balloon angioplasty, a stent was placed across the stenotic lesion. However, the final tici score was 0. Two (2) hours post procedure, the patient developed a symptomatic intracranial hemorrhage (sich) in the distal area of the treated vessel. No medical treatment was provided. Approximately one month post procedure the patient was discharged with modified rankin scale (mrs) of 5. The physician stated that the cause of the sich was a reperfusion injury and the adverse event relationship to the subject device is undeniable.
Patient Sequence No: 1, Text Type: D, B5
[60771673]
The device history record review confirms that the device met all material, assembly and performance specifications. The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed. From the information provided there was no indication that the device was not used as in accordance with the labeling or that this caused or contributed to the reported event. However, hemorrhage is a known risk associated with endovascular procedures and is listed as such in the device directions for use (dfu). Therefore, an assignable cause of anticipated procedural complication was assigned to this event.
Patient Sequence No: 1, Text Type: N, H10
[60771674]
Following an infusion of 24milion units of tissue plasminogen activator, recombinant (rtpa), one pass with the subject retrieval device was successfully performed to treat a right m1 middle cerebral artery occlusion. A thrombolysis in cerebral ischemia (tici) score of 3 was achieved after treatment. Further, it was found that the characteristic of the lesion was atherosclerotic. Therefore, following balloon angioplasty, a stent was placed across the stenotic lesion. However, the final tici score was 0. Two (2) hours post procedure, the patient developed a symptomatic intracranial hemorrhage (sich) in the distal area of the treated vessel. No medical treatment was provided. Approximately one month post procedure the patient was discharged with modified rankin scale (mrs) of 5. The physician stated that the cause of the sich was a reperfusion injury and the adverse event relationship to the subject device is undeniable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002954917-2016-00140 |
| MDR Report Key | 5980298 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-09-27 |
| Date of Report | 2016-09-02 |
| Date of Event | 2015-11-19 |
| Date Mfgr Received | 2016-11-09 |
| Device Manufacturer Date | 2015-04-08 |
| Date Added to Maude | 2016-09-27 |
| 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 | MR. TARA LOPEZ |
| Manufacturer Street | 301 EAST EVELYN |
| Manufacturer City | MOUNTAIN VIEW CA 94041 |
| Manufacturer Country | US |
| Manufacturer Postal | 94041 |
| Manufacturer Phone | 6509382100 |
| Manufacturer G1 | CONCENTRIC MEDICAL |
| Manufacturer Street | 301 EAST EVELYN |
| Manufacturer City | MOUNTAIN VIEW CA 94041 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94041 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TREVO PROVUE |
| Generic Name | CATHETER, THROMBUS RETRIEVER |
| Product Code | MRY |
| Date Received | 2016-09-27 |
| Catalog Number | 90184 |
| Lot Number | 38208 |
| Device Expiration Date | 2017-04-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONCENTRIC MEDICAL |
| Manufacturer Address | 301 EAST EVELYN MOUNTAIN VIEW CA 94041 US 94041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-09-27 |