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

Model Number A35SX050120135

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/25/2017

Event Type  Injury  

Manufacturer Narrative

Upon removal of the stellarex device, embolus and bleeding were noted, thus additional intervention was required.This is being reported as part of the clinical study.Availability to enter this information in section c is still work in progress at spnc, thus the drug information is noted below: stellarex 0.035 otw drug-coated angioplasty balloon, paclitaxel drug, 3.9 mg, therapy date: (b)(6) 2017, adjunct to pta in the treatment of denovo or post pta occluded/ stenotic or restenotic lesions (excluding in-stent) in fem-pop arteries, lot #: ffx17a05a, expiration date: 01/26/2019, (b)(6).Pma number is not applicable.The device has a ce mark that was used in an investigational application./ combination product is applicable.The device was not returned, thus no product evaluation was performed.Per the ifu, embolism and bleeding are listed as a potential complications/adverse events.

Event Description

On (b)(6) 2017, the patient underwent an index procedure of a 290 mm, 90% stenotic de novo lesion of the left proximal, mid and distal sfa.The lesion was predilated using a 4 x 150 mm balloon and inflated to 20 atm, resulting in a residual 50% stenosis.Next, a 5 x 120 mm stellarex balloon was inflated to 16 atm for 3 minutes, resulting in a residual 0% stenosis.Then, a 5 x 120 mm stellarex balloon was inflated to 16 atm for 3 minutes, resulting in a residual 0% stenosis.After, a 5 x 80 mm stellarex balloon was inflated to 18 atm for 3 minutes, resulting in a residual 0% stenosis.Post index procedure, an embolus was noted on the images in the popliteal trifurcation.The clot was successfully retrieved percutaneously with 3 vessel run off.In addition, the patient was bleeding from the groin puncture site, thus 1 suture was applied.The patient was discharged on (b)(6) 2017.The surgeon indicated the incident is highly probably related to the study 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: 6972859
• MDR Text Key: 90088071
• Report Number: 3009784280-2017-00054
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 09/27/2017

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: 01/26/2019
• Device Model Number: A35SX050120135
• Device Catalogue Number: A35SX050120135
• Device Lot Number: FFX17A05A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2017
• Initial Date FDA Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2017
• 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: TERUMO: 6F INTRODUCER SHEATH; TERUMO: RADIOFOCUS 0.035" GUIDE WIRE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 76