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

Model Number A35DC06012013IU

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Occlusion (1984)

Event Date 01/10/2018

Event Type  Injury  

Manufacturer Narrative

The patient required revascularization of the treated lesion.This is being reported as a follow-up to the clinical study.Patient information regarding relevant tests or laboratory data is unknown.This information was not available from the facility.Stellarex 0.035 otw drug-coated angioplasty balloon, paclitaxel drug, 4.7 mg, therapy date: (b)(6) 2015, the stellarex 0.035¿ otw drug-coated angioplasty balloon is indicated for the treatment of de-novo or re- stenotic lesions in the lower extremities to establish blood flow and to maintain vessel patency.Lot #: 15a2961202, expiration date: 08/05/2015.Udi and pma numbers are not applicable.This device was used in a clinical application prior to being available in the us.(b)(6), combination product is applicable.During the index procedure, the product worked as intended, thus no product evaluation was required.Per the ifu, restenosis is listed as a potential complications/adverse events.

Event Description

It was reported through a clinical study that during the index procedure on (b)(6) 2015, two stellarex catheters were used to treat the target lesion of the left mid sfa.Approximately 26 months post index procedure, the patient underwent two revascularizations of the target lesion on (b)(6) 2017.Then, approximately 4 months later, the patient experienced another occlusion.A successful revascularization of the target lesion was performed on (b)(6) 2018.The physician indicated this is not related to the study device or procedure.

• Brand Name: STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON
• Type of Device: DCB PTA CATHETER
• Manufacturer (Section D): SPECTRANETICS; fremont CA
• Manufacturer (Section G): SPECTRANETICS; 6531 dumbarton circle; fremont CA 94555
• Manufacturer Contact: angela abel ; 6655 wedgwood road north; suite 105; maple grove, MN 55311 ; 763955-111
• MDR Report Key: 7210391
• MDR Text Key: 97919706
• Report Number: 3009784280-2018-00002
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/11/2018

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: 08/05/2015
• Device Model Number: A35DC06012013IU
• Device Catalogue Number: A35DC06012013IU
• Device Lot Number: 15A2961202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2018
• Initial Date FDA Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2015
• 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
• Treatment: MFG AND SIZE UNK: GUIDE CATHETER; MFG AND SIZE UNK: GUIDE WIRE; MFG AND SIZE UNK: INTRODUCER SHEATH
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 72