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

Model Number AA14SX035040150

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

Patient Problem Occlusion (1984)

Event Date 10/25/2018

Event Type  Injury  

Manufacturer Narrative

The patient's ethnicity and race are unknown.This information was not available from the facility.The patient required revascularization of the target lesion.This is being reported as part of the clinical study.Cross reference mfr report numbers: 3009784280-2020-00318, 3009784280-2020-00319, 3009784280-2020-00320.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 study.During the index procedure, the product worked as intended and the device was discarded, thus no product evaluation was performed.Per the ifu, occlusion is listed as a potential complications/ adverse events.

Event Description

Hold for ab 12.28 it was reported through a clinical database that during the index procedure on (b)(6) 2018, four stellarex catheters were used to treat the target lesion of the right proximal and distal posterior tibial.Approximately 2 days post index procedure, the patient experienced an occlusion.A successful revascularization of the target lesion was performed on (b)(6) 2018.The physician indicated this is possibly related to the study device and is related to the procedure.

• 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
• Manufacturer (Section G): SPECTRANETICS; 6531 dumbarton circle; fremont CA 94555
• Manufacturer Contact: diana melliza galvez ; 5055 brandin court; fremont, CA 94555 ; 510933-791
• MDR Report Key: 11066531
• MDR Text Key: 224116951
• Report Number: 3009784280-2020-00321
• 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: 12/08/2020

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: 05/26/2019
• Device Model Number: AA14SX035040150
• Device Catalogue Number: AA14SX035040150
• Device Lot Number: FFL17E03A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 83