MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INNOVA¿ VASCULAR; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number H74939293052030

Device Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/16/2017

Event Type  malfunction  

Event Description

While deploying a boston scientific innova stent, the triaxial system failed and didn't fully release the stent.

• Brand Name: INNOVA¿ VASCULAR
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; customer service; 500 commander shea blvd; quincy MA 02171
• MDR Report Key: 7167177
• MDR Text Key: 96460440
• Report Number: 7167177
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2020
• Device Model Number: H74939293052030
• Device Catalogue Number: H74939293052030
• Device Lot Number: 20470018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/26/2017
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/26/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 37