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

Model Number A35SX040120135

Device Problem Insufficient Information (3190)

Patient Problem Vascular Dissection (3160)

Event Date 11/07/2017

Event Type  Injury  

Manufacturer Narrative

Dissection and thrombus were observed during use of the stellarex device.Additional intervention was required to treat the patient, thus resulted in a prolonged procedure.Stellarex 0.035 otw drug-coated angioplasty balloon, paclitaxel drug, 3.3 mg, therapy date: (b)(6) 2017, the stellarex balloon is indicated for the treatment of de-novo or re-stenotic lesions in the lower extremities to establish blood flow and to maintain vessel patency.Lot #: fcw17c23a, expiration date: 04/19/2019, (b)(4).(b)(6).Pma number is not applicable.The device is commercial product with a ce mark./ combination product is applicable the device was disposed, thus no product evaluation was performed.Per the ifu, vessel dissection and thrombosis are listed as potential complications/adverse events of the procedure.

Event Description

The patient had small caliber vessels and given 5000 iv heparin.Ballooned with 4 mm stellarex in the sfa and extensive dissection was noted.The dissection was treated with stents.Thrombus was lodged in the tibial vessel btk.The thrombosis was treated with thrombectomy.

• 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: 7102993
• MDR Text Key: 94357124
• Report Number: 3009784280-2017-00091
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/09/2017

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: 04/19/2019
• Device Model Number: A35SX040120135
• Device Catalogue Number: A35SX040120135
• Device Lot Number: FCW17C23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2017
• Initial Date FDA Received: 12/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2017
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 62