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

Model Number A35SX050040135

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

Patient Problems Gangrene (1873); Unspecified Infection (1930); Necrosis (1971)

Event Date 12/23/2019

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 number: 3009784280-2020-00151.Patient information regarding relevant tests or laboratory data is unknown.This information was not available from the facility.(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 amputation is unrelated to the study device; amputation, necrosis, and infection are listed as potential complications/ adverse events.

Event Description

It was reported through a clinical registry that during the index procedure on (b)(6) 2019, two stellarex catheters were used to treat the target lesion of the right mid sfa and popliteal p1.Approximately 2 weeks post index procedure, the patient experienced gangrene and necrosis.A major amputation of the right lower leg was performed on (b)(6) 2019.Eighteen days later, the patient experienced a non-healing wound and necrosis on the amputation site.Additional amputation of the right lower leg was performed on (b)(6) 2019.Approximately 1 month later, the patient experienced an infection.Additional amputation of the right upper leg, at the knee area was performed on (b)(6) 2019.The physician indicated 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; 6531 dumbarton circle; fremont CA 94555
• Manufacturer (Section G): SPECTRANETICS; 6531 dumbarton circle; fremont CA 94555
• Manufacturer Contact: diana melliza galvez ; 5055 brandin court; fremont, CA 94538 ; 510933-791
• MDR Report Key: 10116920
• MDR Text Key: 194116224
• Report Number: 3009784280-2020-00152
• 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: 01/01/2005,05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2020
• Device Model Number: A35SX050040135
• Device Catalogue Number: A35SX050040135
• Device Lot Number: FCZ18D20A
• 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: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 83