MAUDE Adverse Event Report: SPECTRANETICS STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON; DCB PTA CATHETER

Model Number A35SX050040135

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

Patient Problem Reocclusion (1985)

Event Date 12/10/2019

Event Type  Injury  

Manufacturer Narrative

The patient required revascularization of the target lesion.This is being reported as a follow-up to the clinical study.Cross reference mfr report numbers: 3009784280-2019-00754, 3009784280-2019-00756, 3009784280-2019-00757, 3009784280-2019-00758.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.

Event Description

It was reported through a clinical study that during the index procedure on (b)(6) 2017, four stellarex catheters were used to treat the target lesion of the right proximal, mid, and distal sfa and popliteal, p1 and p3.Approximately 24 months post index procedure, the patient experienced restenosis.A successful revascularization of the target lesion was performed on (b)(6) 2019.

• Brand Name: STELLAREX 0.035 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: sallie heraldo ; 5055 brandin court; fremont, CA 94538 ; 510933-798
• MDR Report Key: 9526728
• MDR Text Key: 176062178
• Report Number: 3009784280-2019-00758
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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: 01/01/2005,12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2019
• Device Model Number: A35SX050040135
• Device Catalogue Number: A35SX050040135
• Device Lot Number: FCZ17K11A
• 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
• Date Manufacturer Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 67