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

Model Number AA14SX025080150

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

Patient Problems Unspecified Infection (1930); Pneumonia (2011); Chronic Obstructive Pulmonary Disease (COPD) (2237)

Event Date 11/26/2020

Event Type  Death  

Event Description

It was reported through a clinical study that during the index procedure on (b)(6) 2020, four stellarex catheters (3011416935-2022-00012, 3011416935-2022-00013, 3011416935-2022-00015) were used to treat the target lesion of the left proximal and distal anterior tibial artery.Approximately 14 months post index procedure, the patient expired due to a refractory infection within already existing copd and pneumonia on (b)(6) 2022.The physician indicated this is not related to the study device or procedure.This adverse event is being submitted because the patient expired due to a refractory infection within already existing copd and pneumonia.This is being reported as a follow-up to the clinical study.

Manufacturer Narrative

The patient's date of birth, ethnicity, and race are unknown.This information was not available from the facility.Foreign- germany/ study name: btk pm- 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 study.During the index procedure, the product worked as intended and the device was discarded, thus no product evaluation was required.Although the cause of death is unrelated to the study device, death is listed in the ifu as a potential complications/ adverse events.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

• Brand Name: STELLAREX 0.014 OTW DRUG-COATED ANGIOPLASTY BALLOON
• Type of Device: DCB PTA CATHETER
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 6655 wedgwood road north; suite 105; maple grove MN 55311
• Manufacturer (Section G): SPECTRANETICS; 6655 wedgwood road north; suite 105; maple grove MN 55311
• Manufacturer Contact: diana melliza galvez ; 6655 wedgwood road north; suite 105; maple grove, MN 55311
• MDR Report Key: 14983234
• MDR Text Key: 295671422
• Report Number: 3011416935-2022-00014
• 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: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2022
• Device Model Number: AA14SX025080150
• Device Catalogue Number: AA14SX025080150
• Device Lot Number: F6E20B05A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2020
• 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): Death
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 98 KG