MAUDE Adverse Event Report: MEDTRONIC IRELAND INTEGRITY RX; STENT, CORONARY

Catalog Number INT40015X

Device Problems Leak/Splash (1354); Increased Sensitivity (2535); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2014

Event Type  malfunction  

Event Description

During an emergency procedure the physician was attempting to implant one integrity bare metal stent in the rca vessel but when the device crossed the lesion the balloon could not inflate.The procedure was completed with a non-mdt stent (4.00mm x 16mm) with no patient complications.Inspection of device was not carried out prior to use as this was an emergency procedure.Evaluation summary: the stent was positioned between the marker bands as per specifications.The 6th distal stent segment was raised and deformed.Visual inspection of the distal shaft detected a tear on the shaft.The tear was 3mm in length and was located approximately 2mm proximal to the balloon bond.The tear was jagged and gaping.Hardened contrast and blood were present in the inflation lumen.The device failed negative prep.Pressure was applied to the device and liquid was seen exiting the tear on the distal shaft.Scratches were also present on the proximal pillow and a 5mm scratch was on the distal shaft located 20mm proximal to balloon bond.

Manufacturer Narrative

Results and conclusions: (given the damage on the device coupled with the manufacturing controls in place to detect this damage, it appears most likely that the issue is related to the attempt to use the device during the procedure and is therefore procedural related).(ifu recommends that the stent be inspected prior use).(stent deformed, leak, shaft tear).(b)(4).

• Brand Name: INTEGRITY RX
• Type of Device: STENT, CORONARY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 4459855
• MDR Text Key: 16173676
• Report Number: 9612164-2015-00125
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2016
• Device Catalogue Number: INT40015X
• Device Lot Number: 0007270828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1