MAUDE Adverse Event Report: ABBOTT VASCULAR INC. GRAFTMASTER; STENT, CORONARY

Model Number 1012581-16

Device Problems Bent (1059); Break (1069); Positioning Failure (1158); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2017

Event Type  malfunction  

Event Description

Upon device removal, were unable to deploy stent.There was difficulty in removing the device.Upon inspection and handling the device the shaft appeared bent and broke outside the body.The patient was not harmed.

• Brand Name: GRAFTMASTER
• Type of Device: STENT, CORONARY
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside dr.; santa clara CA 95054
• MDR Report Key: 6720986
• MDR Text Key: 80283042
• Report Number: 6720986
• Device Sequence Number: 1
• Product Code: MAF
• 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: Other
• Type of Report: Initial
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/30/2019
• Device Model Number: 1012581-16
• Device Catalogue Number: 1012581-16
• Device Lot Number: 7020641
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/27/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/27/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/18/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 92 YR