MAUDE Adverse Event Report: SPECTRANETICS STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON; STELLAREX 035

Model Number A35DC06012013IU

Device Problem Improper Flow or Infusion (2954)

Patient Problem Stenosis (2263)

Event Date 09/13/2017

Event Type  Injury  

Manufacturer Narrative

The patient required revascularization of the target lesion and vessel.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.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 u.S.Study name- (b)(6), patient id # (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 180 mm, 100% stenotic de novo lesion of the left mid sfa.The lesion was predilated using a 5 x 150 mm pta balloon and inflated to 4 atm, resulting in a residual 20% stenosis.Next, a 6 x 120 mm stellarex balloon was inflated to 8 atm for 5 minutes, resulting in a residual 100% stenosis.Then, another 6 x 120 mm stellarex balloon was inflated to 8 atm for 4:05 minutes, resulting in a residual 100% stenosis.After balloon inflation, there was still poor flow distally, thus a 6 x 200 mm stent and a 6 x 60 mm stent were placed in the left mid sfa.Repeated angiography showed that there still remained a poor flow through the left sfa, thus a 4 x 80 mm pta balloon was used for prolonged inflation.Then, a 5.5 x 60 mm stent was placed overlapping the previous stent in the distal portion of the left sfa.The lesion was post dilated with a 4 x 80 mm pta balloon and inflated to 5 atm.Final angiography showed good flow with brisk run off.The patient was discharged per plan.On (b)(6) 2017, the patient underwent revascularization of the target vessel and lesion.The patient was treated with a pta and laser.The procedure was unsuccessful because they were unable to get through the left femoral popliteal.On (b)(6) 2017, the patient underwent an additional revascularization of the 100% restenotic target vessel and lesion, resulting in a final residual 10% stenosis.The patient was discharged the following day.The physician indicated the adverse event is not related to the study device or procedure.

• Brand Name: STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON
• Type of Device: STELLAREX 035
• 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: 6957656
• MDR Text Key: 89611536
• Report Number: 3009784280-2017-00046
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 09/25/2017
• Initial Date FDA Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2015
• Is the Device Single Use?: No
• 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