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

Model Number A35SX050080080

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

Patient Problem Cardiomyopathy (1764)

Event Date 12/19/2016

Event Type  Death  

Manufacturer Narrative

The patient's date of birth, ethnicity and race are unknown.This information was not available from the facility.Cross reference mfr report numbers: 3011416935-2021-00035, 3011416935-2021-00036, 3011416935-2021-00037.Patient information regarding relevant tests/laboratory data is unknown.This information was not available from the facility.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 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.

Event Description

It was reported through a clinical registry that during the index procedure on (b)(6) 2016, four stellarex catheters were used to treat the target lesion of the right proximal, mid, distal sfa and popliteal p1.Approximately 24 months post index procedure, the patient expired due to cardiac decompensation and ischemic cardiomyopathy on (b)(6)2018.The physician reported this is not related to the study device or procedure.This adverse event is being submitted because the patient expired due to cardiac decompensation and ischemic cardiomyopathy.This is being reported as a follow-up to the clinical registry.

• 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: 12628850
• MDR Text Key: 276333837
• Report Number: 3011416935-2021-00038
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: AU
• 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: 03/20/2019

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: 09/20/2018
• Device Model Number: A35SX050080080
• Device Catalogue Number: A35SX050080080
• Device Lot Number: FWU16J08A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/20/2019
• Initial Date FDA Received: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Weight: 83