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

Model Number A35DC05004013IO

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

Patient Problem Pneumonia (2011)

Event Date 12/10/2014

Event Type  Death  

Manufacturer Narrative

The patient's date of birth and race are unknown.This information was not available from the facility.Udi and pma numbers are not applicable.This device was used in clinical application prior to being available in the us.Report source: foreign- (b)(6)/ study name: (b)(6): patient id #: (b)(6).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 study that during the index procedure on (b)(6) 2014, a stellarex catheter was used to treat the target lesion of the right mid sfa.Approximately 38 months post index procedure, the patient expired due to pulmonary infection on (b)(6) 2018.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 pulmonary infection.This is being reported as a follow-up to the clinical study.

• 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
• 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: 12628900
• MDR Text Key: 276333728
• Report Number: 3011416935-2021-00034
• 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: 11/23/2018

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: 04/13/2015
• Device Model Number: A35DC05004013IO
• Device Catalogue Number: A35DC05004013IO
• Device Lot Number: 14K0750401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/23/2018
• Initial Date FDA Received: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 96 YR
• Patient Weight: 55