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

Model Number AA14SX030040090

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

Patient Problem Unspecified Infection (1930)

Event Date 01/10/2020

Event Type  Injury  

Manufacturer Narrative

The patient required amputation on the treated limb.This is being reported as a follow-up to the clinical registry.Cross reference mfr report numbers: 3009784280-2020-00026.Patient information regarding relevant tests or 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/510k: 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.Per the ifu, infection and amputation are listed as potential complications/adverse events.

Event Description

It was reported through a clinical registry that during the index procedure on (b)(6) 2018, two stellarex catheters were used to treat the target lesions of the left infrapopliteal, tibioperoneal trunk and distal tibialis anterior.Approximately 13 months post index procedure, the patient experienced osteomyelitis and soft tissue infection.A major amputation of the target limb was performed on (b)(6) 2020.The physician indicated this is not related to the study device or procedure.

• 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
• Manufacturer (Section G): SPECTRANETICS; 6531 dumbarton circle; fremont CA 94555
• Manufacturer Contact: ana tan ; 5055 brandin court; fremont, CA 94538 ; 510933-798
• MDR Report Key: 9656320
• MDR Text Key: 177754512
• Report Number: 3009784280-2020-00025
• 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: 01/01/2005,01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2019
• Device Model Number: AA14SX030040090
• Device Catalogue Number: AA14SX030040090
• Device Lot Number: FEK17E03A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 62