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

Model Number A35DC05012013IO

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 07/14/2017

Event Type  Injury  

Manufacturer Narrative

The patient's age or dob at time of event, gender, and weight are unknown.This information was not available from the facility.The patient required revascularization of the target lesion.The patient was hospitalized for 2 days.This is being reported as a follow-up to the clinical study.Patient information regarding relevant tests/laboratory data or medical history are unknown.This information was not available from the facility.Stellarex 0.035 otw drug-coated angioplasty balloon, paclitaxel drug, 3.9 mg, therapy date: (b)(6) 2013, adjunct to pta in the treatment of denovo or post pta occluded/ stenotic or restenotic lesions (excluding in-stent) in fem-pop arteries, lot #: 13b265120-2, expiration date: 05/29/2013.Serial number is unknown.This information was not collected during the study.Udi and pma numbers are not applicable.This device was used in 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

On (b)(6) 2013, the patient underwent an index procedure of a 100 mm, 98% stenotic de novo lesion of the right proximal sfa.The lesion was predilated using a 4 x 40 mm balloon and inflated to 12 atm, resulting in a residual 40% stenosis.Then, a 5 x 120 mm stellarex balloon was inflated to 12 atm for 2 1/2 minutes, resulting in a residual 20% stenosis.On (b)(6) 2017, the patient was admitted to the hospital for restenosis and denovo stenosis of the right mid sfa of the target lesion.On (b)(6) 2017, the patient was treated with a pta deb and discharged the following day.The site indicated this is not related to the study procedure or study device.

• 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: florie cazem ; 5055 brandin court; fremont, CA 94538 ; 510933-792
• MDR Report Key: 6880611
• MDR Text Key: 86986062
• Report Number: 3009784280-2017-00032
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/29/2017

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: 05/29/2013
• Device Model Number: A35DC05012013IO
• Device Catalogue Number: A35DC05012013IO
• Device Lot Number: 13B265120-2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2017
• Initial Date FDA Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2013
• 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