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 Problems Gangrene (1873); Unspecified Infection (1930); Necrosis (1971)

Event Date 01/06/2020

Event Type  Injury  

Manufacturer Narrative

The patient required amputation on the treated limb.This is being reported as a follow-up to the clinical registry.Patient information regarding relevant tests or 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 (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.Per the ifu, necrosis, infection, and amputation are listed as potential complications/adverse events.

Event Description

It was reported through a clinical registry that during the index procedure on (b)(6) 2019, a stellarex catheter was used to treat the target lesion of the right distal sfa.Approximately 2 months post index procedure, the patient experienced complications of fontaine stage iv (necrosis and gangrene).A transgenual amputation of the target limb was performed on (b)(6) 2019.Approximately 1 month later, the patient experienced an infection of the previous amputation site and a transfemoral amputation of the target limb was performed on (b)(6) 2020.

• Brand Name: STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON
• Type of Device: DCB PTA CATHETER
• Manufacturer (Section D): SPECTRANETICS; 6531 dumbarton circle; fremont CA 94555
• Manufacturer (Section G): SPECTRANETICS; 6531 dumbarton circle; fremont CA 94555
• Manufacturer Contact: ana tan ; 5055 brandin court; fremont, CA 94538 ; 510933-798
• MDR Report Key: 10048017
• MDR Text Key: 194114779
• Report Number: 3009784280-2020-00131
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: NL
• 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: 01/01/2005,04/29/2020

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 04/29/2020
• Initial Date FDA Received: 05/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 123