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

Model Number A35DC06012013IU

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

Patient Problems Calcium Deposits/Calcification (1758); Stenosis (2263); Claudication (2550)

Event Date 08/02/2017

Event Type  Injury  

Manufacturer Narrative

At the two year follow-up, a duplex ultrasound showed a calcified plaque in the treated lesion.As a result, the patient required revascularization using a pta balloon, stent implantation, and atherectomy.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, 4.7 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 #: 15a2961202, expiration date: 08/05/2015.Udi and pma numbers are not applicable.This device was used in clinical application prior to being available in the us.Study name- (b)(6), patient (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 the index procedure for treatment of a 140 mm, 90% stenotic denovo lesion in the right mid-sfa.The lesion was predilated initially with a 5 x 120 mm balloon at 8 atm and using a second 5 x 120 mm balloon which was inflated two times.Residual stenosis following predilatation was 60%.Next, a 6 x 120 mm stellarex balloon was inflated to 8 atm for 5 minutes.Then, a second stellarex 5 x 80 mm balloon was inflated to 6 atm for 5 minutes, resulting in a residual stenosis of 10%.No complications occurred and the subject was discharged as per plan on (b)(6) 2015.At the 2 year follow-up visit on (b)(6) 2017, a duplex ultrasound showed calcified plaque in the right mid sfa.On (b)(6) 2017, the patient complained of bilateral lower extremity claudication.On (b)(6) 2017, the patient underwent a successful revascularization procedure of the right mid sfa using pta, stent implantation and atherectomy.The physician has indicated that it is unlikely that the event is related to the 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: florie cazem ; 5055 brandin court; fremont, CA 94538 ; 510933-792
• MDR Report Key: 6815983
• MDR Text Key: 83474795
• Report Number: 3009784280-2017-00006
• 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: 08/04/2017

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: 08/05/2015
• 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: 08/04/2017
• Initial Date FDA Received: 08/23/2017
• 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): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 87