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

Model Number AA14SX025150150

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

Patient Problem Death (1802)

Event Date 03/21/2019

Event Type  Death  

Manufacturer Narrative

The patient's ethnicity and race are unknown.This information was not available from the facility.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 study.Udi and pma numbers are not applicable.This device was used in clinical application prior to being available in the us.(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) 2019, a stellarex catheter was used to treat the target lesion of the left proximal and distal anterior tibial artery.Approximately 20 months post index procedure, the patient expired due to respiratory insufficiency caused by covid 19 virus and heart failure on (b)(6) 2020.The physician indicated this is not related to the study device or procedure.

Manufacturer Narrative

Block g3: corrected study name from illuminate btk pm to btk pm.Block g5: pma number is not applicable.The device is a commercial product with a ce mark that was used as part of a clinical study.

• Brand Name: STELLAREX 0.014 OTW DRUG-COATED ANGIOPLASTY BALLOON
• Type of Device: DCB PTA CATHETER
• Manufacturer (Section D): SPECTRANETICS; 6531 dumbarton circle; fremont CA 94555
• MDR Report Key: 11051899
• MDR Text Key: 223050394
• Report Number: 3009784280-2020-00317
• 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: 12/01/2020

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: 11/29/2020
• Device Model Number: AA14SX025150150
• Device Catalogue Number: AA14SX025150150
• Device Lot Number: F8E18L08A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 48