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

Model Number A35SX050120080

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Ischemia (1942); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/15/2018

Event Type  Death  

Manufacturer Narrative

The patient's 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.

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 28 months post index procedure, the patient expired due to critical limb ischemia on (b)(6) 2020.Per clinical evaluation, this is not related to the device or procedure.

Manufacturer Narrative

Block h6: added code 1802 (death).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.

Manufacturer Narrative

Block b5: added additional causes of death provided by the study site.Block h6: added codes 1914 (low blood pressure/ hypotension) and 4581 (appropriate term / code not available).

Event Description

Additional information received on 09jun2021: the study site confirmed the patient expired due to leg ischemia, pvd (peripheral vascular disease), type 2 diabetes, and hypotension.

• Brand Name: STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON
• Type of Device: DCB PTA CATHETER
• Manufacturer (Section D): SPECTRANETICS; 6531 dumbarton circle; fremont CA 94555
• MDR Report Key: 11926105
• MDR Text Key: 253959086
• Report Number: 3009784280-2021-00056
• 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: distributor,foreign,study
• Type of Report: Initial,Followup,Followup
• Report Date: 05/14/2021

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: 12/02/2018
• Device Model Number: A35SX050120080
• Device Catalogue Number: A35SX050120080
• Device Lot Number: FWV16L18A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/14/2021
• Initial Date FDA Received: 06/02/2021
• Supplement Dates Manufacturer Received: 06/06/2021; 06/09/2021
• Supplement Dates FDA Received: 06/08/2021; 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 81 YR
• Patient Weight: 80