MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,study report with the FDA on 2020-03-23 for STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON manufactured by Spectranetics.
[188438521]
The patient experienced distal embolization. This is being reported as part of the clinical registry. Cross reference mfr report numbers: 3009784280-2020-00078, 3009784280-2020-00079, 3009784280-2020-00080. Patient information regarding relevant tests/laboratory data is unknown. This information was not available from the facility. The lot number was not provided in the registry, thus the following information are unknown: unique id, model #, catalog #, expiration date, and manufacture date report source: foreign- (b)(6)/study name: (b)(6): patient id #(b)(6). Pma number is not applicable. The device is a commercial product with a ce mark that was used as part of a clinical registry. During the index procedure, there was no report of a device malfunction. Device was discarded, thus no product evaluation was performed. Per the ifu, embolism is listed as a potential complications/adverse events.
Patient Sequence No: 1, Text Type: N, H10
[188438522]
It was reported through a clinical registry that during the index procedure on (b)(6) 2018, three stellarex catheters were used to treat the target lesion of the left mid sfa. During the procedure, the patient experienced distal embolization, which required revascularization of the target lesion. The physician indicated this is related to the use of the study device and procedure, however there was no report of a device malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009784280-2020-00078 |
| MDR Report Key | 9869405 |
| Report Source | FOREIGN,STUDY |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-11 |
| Date of Event | 2018-12-21 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-11 |
| Date Added to Maude | 2020-03-23 |
| 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 | MS. ANA TAN |
| Manufacturer Street | 5055 BRANDIN COURT |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal | 94538 |
| Manufacturer Phone | 510933-798 |
| Manufacturer G1 | SPECTRANETICS |
| Manufacturer Street | 6531 DUMBARTON CIRCLE |
| Manufacturer City | FREMONT CA 94555 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94555 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON |
| Generic Name | DCB PTA CATHETER |
| Product Code | ONU |
| Date Received | 2020-03-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPECTRANETICS |
| Manufacturer Address | 6531 DUMBARTON CIRCLE FREMONT CA 94555 US 94555 |
| Brand Name | PACLITAXEL, 2 ?G/MM2 |
| Product Code | --- |
| Date Received | 2020-03-23 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Manufacturer | SPECTRANETICS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-23 |