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

Model Number A35SX060040080

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

Patient Problem Claudication (2550)

Event Date 01/23/2019

Event Type  Injury  

Manufacturer Narrative

The patient's weight is unknown.This information was not available from the facility.The patient required amputation on the treated limb.This is being reported as a follow-up to the clinical registry.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 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, pain (claudication) 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, a stellarex balloon catheter was used to treat the target lesion of the left proximal sfa in a claudicant patient.Approximately 8 months post index procedure, the patient underwent an amputation of the target limb (no further details are available) on (b)(6)2019.Per clinical evaluation, the amputation is not related to the study device or the procedure.

Manufacturer Narrative

Block b5: included initial amputation that occurred on (b)(6) 2018 and provided cause of amputation for the event on (b)(6) 2019.H3 other text : placeholder.

Event Description

Approximately 5 months post index procedure, the patient underwent a transtibial amputation of the target limb due to gangrene on (b)(6) 2018.Then approximately 3 months later, the patient experienced constant pain on the non-healing amputation site and underwent a transfemoral amputation of the target limb on (b)(6) 2019.Per clinical evaluation, the amputations are not related to the study device or the 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
• MDR Report Key: 9485154
• MDR Text Key: 176234591
• Report Number: 3009784280-2019-00730
• 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: foreign,study
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/25/2019

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: 04/27/2019
• Device Model Number: A35SX060040080
• Device Catalogue Number: A35SX060040080
• Device Lot Number: FBZ17D10A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 01/30/2020
• Supplement Dates FDA Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR