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 Embolism (1829)

Event Date 12/21/2018

Event Type  Injury  

Manufacturer Narrative

The patient experienced distal embolization.This is being reported as part of the clinical registry.Cross reference mfr report numbers: 3009784280-2020-00078, 3009784280-2020-00079, 3009784280-2020-00080.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, there was no report of a device malfunction.Device was discarded, thus no product evaluation was performed.Per the ifu, embolism is listed as a potential complications/adverse events.

Event Description

It was reported through a clinical registry that during the index procedure on (b)(6) 2018, three stellarex catheters were used to treat the target lesion of the left mid sfa.During the procedure, the patient experienced distal embolization, which required revascularization of the target lesion.The physician indicated this is related to the use of the study device and procedure, however there was no report of a device malfunction.

• 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: 9869405
• MDR Text Key: 188438521
• Report Number: 3009784280-2020-00078
• 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: 01/01/2005,03/11/2020

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: 03/11/2020
• Initial Date FDA Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 93