MAUDE Adverse Event Report: SPECTRANETICS STELLAREX 0.014 OTW DRUG-COATED ANGIOPLASTY BALLOON; DCB PTA CATHETER

Model Number AA14SX020080090

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reocclusion (1985)

Event Date 11/15/2019

Event Type  Injury  

Manufacturer Narrative

The patient required revascularization of the target lesion.This is being reported as a follow-up to the clinical registry.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).Block g5: pma number is not applicable.The device is a commercial product with a ce mark that was used as part of a clinical registry.Block h3: during the index procedure, the product worked as intended and the device was discarded, thus no product evaluation was performed.Block h6: per the ifu, restenosis is listed as a potential complications/adverse events.H3 other text : placeholder.

Event Description

It was reported through a clinical registry that during the index procedure on (b)(6) 2018, a stellarex catheter was used to treat the target lesion of the left infrapopliteal and proximal peroneal.Approximately 14 months post index procedure, the patient experienced restenosis.A successful revascularization of the target lesion was performed on (b)(6) 2019.

• Brand Name: STELLAREX 0.014 OTW DRUG-COATED ANGIOPLASTY BALLOON
• Type of Device: DCB PTA CATHETER
• Manufacturer (Section D): SPECTRANETICS; 6531 dumbarton circle; fremont CA 94555
• Manufacturer (Section G): SPECTRANETICS; 6531 dumbarton circle; fremont CA 94555
• Manufacturer Contact: ana tan ; 5055 brandin court; fremont, CA 94538 ; 510933-798
• MDR Report Key: 9431140
• MDR Text Key: 169732627
• Report Number: 3009784280-2019-00701
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2019
• Device Model Number: AA14SX020080090
• Device Catalogue Number: AA14SX020080090
• Device Lot Number: FEB17F11A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 96