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

Model Number A35SX050120135

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

Patient Problem Cardiomyopathy (1764)

Event Date 11/14/2019

Event Type  Death  

Manufacturer Narrative

The patient's cause of death was unrelated to the study device or procedure.This is being reported as a follow-up to the clinical registry.Foreign report source: (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 required.(b)(4).

Event Description

It was reported through a clinical registry that during the index procedure on (b)(6) 2019, a stellarex catheter was used to treat the target lesion of the right mid and distal sfa.Approximately 16 months post index procedure, the patient expired due to ischemic cardiomyopathy on (b)(6) 2021.The physician indicated this is not related to the study device or procedure.

Manufacturer Narrative

Block h6: added code 1802 (death).Although the cause of death is unrelated to the study device, death is listed in the ifu as a potential complications/ adverse events.Component codes intentionally left blank.No device malfunction was reported during the index procedure.

Manufacturer Narrative

Block h1 (no.Of events (noe) summarized): in the initial report, the xml file shows the summary report and 123 events were included.However, this was inadvertently included due to a system error in the xml file, as it was not visible in the pdf copy.This field should be left blank.

• 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: 11584663
• MDR Text Key: 242811025
• Report Number: 3009784280-2021-00035
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: AU
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Foreign,Study,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2021

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: 04/17/2021
• Device Model Number: A35SX050120135
• Device Catalogue Number: A35SX050120135
• Device Lot Number: F2C19C28A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/19/2021
• Initial Date FDA Received: 03/29/2021
• Supplement Dates Manufacturer Received: 06/06/2021; 03/09/2022
• Supplement Dates FDA Received: 06/08/2021; 03/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 82 KG