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

Model Number A35SX060080135

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

Patient Problem Cancer (3262)

Event Date 12/12/2019

Event Type  Death  

Manufacturer Narrative

Cross reference mfr report numbers: 3011416935-2021-00013.The lot number was not provided in the registry, thus the following information are unknown: unique id, model #, lot #, catalog #, dose, expiration date, and manufacture date.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 required.Although the cause of death is unrelated to the study device, death 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) 2019, two stellarex catheters were used to treat the target lesion of the left proximal and mid sfa.Approximately 16 months post index procedure, the patient expired due to cancer on (b)(6) 2021.The physician reported this is not related to the study device or procedure.This adverse event is being submitted because the patient expired due to cancer.This is being reported as a follow-up to the clinical registry.

Manufacturer Narrative

Block c1/c3/c7/d4/h4: the lot number was added in the registry, thus the following information were entered: unique id, model #, lot #, catalog #, dose, expiration date, and manufacture date.

• Brand Name: STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON
• Type of Device: DCB PTA CATHETER
• Manufacturer (Section D): SPECTRANETICS; 6655 wedgwood road north; suite 105; maple grove MN 55311
• MDR Report Key: 12334483
• MDR Text Key: 267024534
• Report Number: 3011416935-2021-00014
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Type of Report: Initial,Followup
• Report Date: 07/21/2021

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: 05/23/2023
• Device Model Number: A35SX060080135
• Device Catalogue Number: A35SX060080135
• Device Lot Number: F8C19D29A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 08/17/2021
• Supplement Dates Manufacturer Received: 08/20/2021
• Supplement Dates FDA Received: 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 84