MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,study report with the FDA on 2020-03-25 for STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON A35SX060120135 manufactured by Spectranetics.
[188406829]
The patient required revascularization of the target lesion. This is being reported as a follow-up to the clinical study. Cross reference mfr report numbers: 3009784280-2020-00091, 3009784280-2020-00092, 3009784280-2020-00093. Report source: foreign- (b)(6)/ study name: (b)(6): patient id (b)(6). Pma number is not applicable. The device is a non-commercial product with a ce mark that was used as part of a clinical study. During the index procedure, the product worked as intended and the device was discarded, thus no product evaluation was performed. Per the ifu, restenosis is listed as a potential complications/adverse events.
Patient Sequence No: 1, Text Type: N, H10
[188406830]
It was reported through a clinical study that during the index procedure on (b)(6) 2019, three stellarex catheters were used to treat the target lesion of the left proximal, mid, and distal sfa. Approximately 8 months post index procedure, the patient experienced restenosis. A successful revascularization of the target lesion was performed on (b)(6) 2019. The physician indicated this is not related to the study device or procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009784280-2020-00092 |
| MDR Report Key | 9878157 |
| Report Source | FOREIGN,STUDY |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-20 |
| Date of Event | 2019-11-13 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-20 |
| Date Added to Maude | 2020-03-25 |
| 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 | 2020-03-25 |
| Model Number | A35SX060120135 |
| Catalog Number | A35SX060120135 |
| Lot Number | FG618B03A |
| Device Expiration Date | 2020-02-14 |
| 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 | 2020-03-25 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Manufacturer | SPECTRANETICS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-25 |