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

Catalog Number INT27514X

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2013

Event Type  malfunction  

Event Description

The physician intended to deploy an integrity 2.75x14mm bare metal stent to treat a cx lesion with discrete calcification, tortuosity and 80% stenosis.Physician inflated a 2.50 x 12 mm balloon twice at 14 atm at the target lesion with no difficulties encountered.50% stenosis remained after pre-dilation.It is reported that several attempts were then made to cross the lesion with the resolute integrity device and force was used during attempted positioning.The stent failed to be positioned.The stent was removed as a whole along with the guide wire and catheter.It is reported the stent did not become loose from the catheter inside the patient but dislodged from the catheter upon removal from the patient.A second stent of unknown size or brand was used to complete procedure.There were no patient complications reported.Evaluation summary: the hypotube was kinked immediately distal to the end of the strain relief.The distal tip was stubbed.The stent was not present on the balloon and was not returned with the delivery system.The balloon was uninflated.Crimp/bake impressions were visible on the balloon.

Manufacturer Narrative

Evaluation results: failure to follow instructions (ifu contravened - force used).Patient¿s condition affected effectiveness of device (lesion morphology).Evaluation conclusions: device failure related to patient condition (lesion morphology).User error contributed to event (ifu contravened - force used).(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: 3811736
• MDR Text Key: 4527995
• Report Number: 9612164-2014-00516
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 04/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2014
• Device Catalogue Number: INT27514X
• Device Lot Number: 0006256138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2014
• Date Device Manufactured: 07/05/2012
• 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
• Patient Age: 00060 YR