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

Model Number A35DC04012013IO

Device Problems Occlusion Within Device (1423); Improper or Incorrect Procedure or Method (2017)

Patient Problem Stenosis (2263)

Event Date 03/14/2017

Event Type  Injury  

Manufacturer Narrative

The patient required revascularization of the target vessel.The patient was hospitalized for 9 days.This is being reported as a follow-up to the clinical study.Stellarex 0.035 otw drug-coated angioplasty balloon, paclitaxel drug, 3.3 mg, therapy date: (b)(6) 2015, adjunct to pta in the treatment of denovo or post pta occluded/ stenotic or restenotic lesions (excluding in-stent) in fem-pop arteries, lot #: 15b1141202, expiration date: 08/08/2015, udi and pma numbers are not applicable.This device was used in clinical application prior to being available in the us.Foreign- (b)(6) / study name- (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) 2015, the patient underwent an index procedure of a 150 mm, 100% stenotic denovo lesion of the left mid-sfa.The lesion was pre-treated with pta and predilated with a 4 x 100 mm balloon and inflated to 10 atm, resulting in a residual 70% stenosis.Next, a 4 x 120 mm stellarex balloon was inflated to 10 atm for 3 minutes, resulting a residual 65% stenosis.Then, a 4 x 80 mm stellarex balloon was inflated to 10 atm for 3 minutes, resulting in a residual 65% stenosis.The target lesion was post-dilated at 12 atm, resulting in a residual 50% stenosis.Two (2) stents were placed due to the residual stenosis.No complications occurred.The patient was discharged per plan.On 06/08/2016, a event of ''stent occlusion in left sfa'' was reported as being ''treated conservatively''.On (b)(6) 2017, the patient was hospitalized and a femoral popliteal bypass procedure was completed on left sfa.The patient was discharged on 0(b)(6) 2017.The physician indicated that the adverse event is possibly related to the device and 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: florie cazem ; 5055 brandin court; fremont, CA 94538 ; 510933-792
• MDR Report Key: 6880591
• MDR Text Key: 87188192
• Report Number: 3009784280-2017-00030
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 08/28/2017

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: 08/18/2015
• Device Model Number: A35DC04012013IO
• Device Catalogue Number: A35DC04012013IO
• Device Lot Number: 15B1141202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2017
• Initial Date FDA Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2015
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 74