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

Model Number A35SX060120135

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

Patient Problem Reocclusion (1985)

Event Date 11/03/2020

Event Type  Injury  

Manufacturer Narrative

The patient's ethnicity and race are unknown.This information was not available from the facility.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: 3009784280-2020-00299, 3009784280-2020-00300.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.Although the cause of restenosis is unrelated to the study device, restenosis is listed in the ifu as a potential complications/ adverse events.

Event Description

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 right distal sfa and popliteal p1.Approximately 26 months post index procedure, the patient experienced restenosis.A successful revascularization of the target lesion was performed on (b)(6) 2020.Per clinical evaluation, this is not related to the study device or procedure.

• 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: diana melliza galvez ; 5055 brandin court; fremont, CA 94538 ; 719377-898
• MDR Report Key: 10830553
• MDR Text Key: 216608883
• Report Number: 3009784280-2020-00298
• 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: 11/04/2020

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: 03/07/2020
• Device Model Number: A35SX060120135
• Device Catalogue Number: A35SX060120135
• Device Lot Number: FJW18B21A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 113