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

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 08/13/2018

Event Type  Injury  

Manufacturer Narrative

The patient's date of birth, ethnicity and race are unknown.This information was not available from the facility.Patient information regarding relevant tests/laboratory data is unknown.This information was not available from the facility.The lot number was not provided in the registry, thus the following information are unknown: unique id, model #, catalog #, expiration date, and manufacture date report source 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 amputation is unrelated to the study device, amputation 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) 2018, a stellarex catheter was used to treat the target lesion of the left distal sfa.Approximately 4 months post index procedure, the patient experienced recurrent wound infection.A major amputation of the target limb was performed on (b)(6) 2018.Per clinical evaluation, this is not related to the study device or procedure.This adverse event is being submitted because the patient required amputation of the target limb.This is being reported as a follow-up to the clinical registry.

• Brand Name: STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON
• Type of Device: DCB PTA CATHETER
• Manufacturer (Section D): SPECTRANETICS
• MDR Report Key: 12701242
• MDR Text Key: 283979413
• Report Number: 3011416935-2021-00042
• 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
• Report Date: 08/07/2019

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/07/2019
• Initial Date FDA Received: 10/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 136