• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SPECTRANETICS STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON; DCB PTA CATHETER Back to Search Results
Model Number A35SX060080080
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Sepsis (2067); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 06/28/2018
Event Type  Death  
Manufacturer Narrative
The patient's date of birth, ethnicity and race are unknown.This information was not available from the facility.The patient's cause of death was unrelated to the study device or procedure.This is being reported as a follow-up to the clinical registry.Patient information regarding relevant tests/laboratory data is unknown.This information was not available from the facility.Report source: foreign: (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 registry.During the index procedure, the product worked as intended and the device was discarded, thus no product evaluation was required.Although the cause of death is unrelated to the study device, death is listed in the ifu as a potential complications/ adverse events.Component codes intentionally left blank.No device malfunction was reported during the index procedure.
 
Event Description
It was reported through a clinical registry that during the index procedure on (b)(6)2018, a stellarex catheter was used to treat the target lesion of the right distal sfa.Approximately 32 months post index procedure, the patient expired due to covid 19 infection and sepsis (due to infection of prosthesis) on (b)(6) 2021.The physician indicated this is not related to the study device or procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON
Type of Device
DCB PTA CATHETER
Manufacturer (Section D)
SPECTRANETICS
6655 wedgwood road north
suite 105
maple grove MN 55311
Manufacturer (Section G)
SPECTRANETICS
6655 wedgwood road north
suite 105
maple grove MN 55311
Manufacturer Contact
diana melliza galvez
6655 wedgwood road north
suite 105
maple grove, MN 55311
MDR Report Key12170732
MDR Text Key261640383
Report Number3011416935-2021-00002
Device Sequence Number1
Product Code ONU
Combination Product (y/n)Y
Reporter Country CodeBE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,study
Reporter Occupation Physician
Type of Report Initial
Report Date 07/02/2021
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 Date12/11/2019
Device Model NumberA35SX060080080
Device Catalogue NumberA35SX060080080
Device Lot NumberFCS17L16A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/02/2021
Initial Date FDA Received07/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age80 YR
Patient Weight90
-
-