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

Catalog Number INT25026X

Device Problems Component or Accessory Incompatibility (2897); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2013

Event Type  malfunction  

Event Description

The physician was attempting to deliver an integrity bare metal stent, however, it got stuck in the guidewire and was damaged.The device was removed and replaced with another stent.Patient recovered.No clinical sequelae were reported.

Manufacturer Narrative

Evaluation results: (root cause could not be determined).(no results available since no evaluation performed) - device or procedural images not provided for review.Device not returned for evaluation.Evaluation conclusions: (root cause could not be determined).(b)(4).

Manufacturer Narrative

Evaluation, results: related to operational context ¿damage to the stent is most likely due to the attempts to cross the lesion.(deformation problem).Conclusions: related to operational context ¿damage to the stent is most likely due to the attempts to cross the lesion.(b)(4).

Event Description

Evaluation summary: the device was returned for analysis to medtronic.There was no resistance noted when a 0.015" mandrel was passed through the wire lumen entry port through to the tip.The stent was not positioned on the balloon it was placed on the stylette and was severely deformed and stretched.It was noted that the hypotube had kinks at 5cm, 43.5cm, 55cm and 59cm distal to the strain relief.

• 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: 3610085
• MDR Text Key: 19804719
• Report Number: 9612164-2014-00082
• 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,Followup
• Report Date: 04/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2014
• Device Catalogue Number: INT25026X
• Device Lot Number: 0006381891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2012
• 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: 00054 YR