MAUDE Adverse Event Report: SPECTRANETICS STELLAREX 0.014 OTW DRUG-COATED ANGIOPLASTY BALLOON; DCB PTA CATHETER

Model Number AA14SX040150150

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

Patient Problem Thrombus (2101)

Event Date 12/12/2018

Event Type  Injury  

Manufacturer Narrative

The patient required intervention of the treated lesion.This is being reported as a part of a clinical study.Report source: foreign- (b)(6).Study name: (b)(6)- patient id #(b)(6).Pma number is not applicable.The device is a commercial product with a ce mark that was used as part of a clinical study.During the index procedure, the product worked as intended, thus no product evaluation was required.Per the ifu, thrombosis is listed as a potential complications/adverse events.

Event Description

It was reported through a clinical study that during the index procedure on (b)(6) 2018, three stellarex catheters were used to treat the target lesion of the right p3 and tp.After the procedure, the patient experienced thrombus inflow on the target lesion, thus stent placement was required.

Manufacturer Narrative

Model and catalog number corrected from a14sx040150150t to aa14sx040150150.

• Brand Name: STELLAREX 0.014 OTW DRUG-COATED ANGIOPLASTY BALLOON
• Type of Device: DCB PTA CATHETER
• Manufacturer (Section D): SPECTRANETICS; 6531 dumbarton circle; fremont CA 94555
• MDR Report Key: 8605987
• MDR Text Key: 144940067
• Report Number: 3009784280-2019-00162
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,04/29/2019

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: 08/07/2020
• Device Model Number: AA14SX040150150
• Device Catalogue Number: AA14SX040150150
• Device Lot Number: F5H18H02A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 04/29/2019
• Initial Date FDA Received: 05/13/2019
• Supplement Dates Manufacturer Received: 07/11/2019
• Supplement Dates FDA Received: 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 83