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

Model Number A35SX050120135

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

Patient Problems Respiratory Failure (2484); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/01/2020

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.Cross reference mfr report numbers: 3011416935-2021-00004.Patient information regarding relevant tests/laboratory data is unknown.This information was not available from the facility.Report source: foreign- (b)(6)/ study name: saver: 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 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.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) 2021, two stellarex catheters were used to treat the target lesion of the right proximal, mid sfa.Approximately 9 months post index procedure, the patient expired due to respiratory failure during hospitalization for sigmoid diverticulosis on (b)(6) 2021.The physician reported this is not related to the study device or procedure.

• 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 Key: 12240920
• MDR Text Key: 263933949
• Report Number: 3011416935-2021-00003
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2021

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 Date: 12/02/2021
• Device Model Number: A35SX050120135
• Device Catalogue Number: A35SX050120135
• Device Lot Number: F2C19K31A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/30/2021
• Initial Date FDA Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 60