STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON A35SX060040080

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,study report with the FDA on 2020-03-24 for STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON A35SX060040080 manufactured by Spectranetics.

Event Text Entries

[188405910] The patient required revascularization of the target lesion. This is being reported as a follow-up to the clinical registry. Cross reference mfr report numbers: 3009784280-2020-00086, 3009784280-2020-00087. Patient information regarding relevant tests/laboratory data is unknown. This information was not available from the facility. 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, 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


[188405911] It was reported through a clinical registry that during the index procedure on (b)(6) 2018, two stellarex catheters were used to treat the target lesion of the left mid sfa. Approximately 21 months post index procedure, the patient experienced restenosis. A successful revascularization of the target lesion was performed on 10/10/2019.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3009784280-2020-00086
MDR Report Key9875720
Report SourceFOREIGN,STUDY
Date Received2020-03-24
Date of Report2020-03-20
Date of Event2019-10-10
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-03-20
Date Added to Maude2020-03-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. ANA TAN
Manufacturer Street5055 BRANDIN COURT
Manufacturer CityFREMONT CA 94538
Manufacturer CountryUS
Manufacturer Postal94538
Manufacturer Phone510933-798
Manufacturer G1SPECTRANETICS
Manufacturer Street6531 DUMBARTON CIRCLE
Manufacturer CityFREMONT CA 94555
Manufacturer CountryUS
Manufacturer Postal Code94555
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameSTELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON
Generic NameDCB PTA CATHETER
Product CodeONU
Date Received2020-03-24
Model NumberA35SX060040080
Catalog NumberA35SX060040080
Lot NumberFBZ17D10A
Device Expiration Date2019-04-27
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerSPECTRANETICS
Manufacturer Address6531 DUMBARTON CIRCLE FREMONT CA 94555 US 94555

Device Sequence Number: 101

Brand NamePACLITAXEL, 2 ?G/MM2
Product Code---
Date Received2020-03-24
Device Sequence No101
Device Event Key0
ManufacturerSPECTRANETICS


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2020-03-24

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