MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE INTEGRITY RX; STENT, CORONARY, DRUG-ELUTING

Model Number RSINT35030JX

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2016

Event Type  malfunction  

Event Description

It was reported that the physician was attempting to use a resolute integrity rx drug eluting stent to treat a non-tortuous and non- calcified lad lesion exhibiting 90% stenosis.No damage noted to device packaging and no issues were noted when removing the devices from the hoop/tray.The device was inspected and negative prep performed with no issues noted.A 7f non-medtronic guide catheter was prepped as per ifu, with no damage noted prior to use.It was reported that the lesion was not pre-dilated.During the procedure it was reported that the device did not pass through a previously deployed stent.No resistance was encountered when advancing the device or excessive force used.The stent was expanded evenly and sufficiently along the entire length.After stent deployment it was reported that removal difficulties were encountered, the device became stuck while it was retracted from the guiding catheter and it was removed by exerting a force.Sufficient time was given to allow the balloon to fully deflate prior to attempting to remove the device.No resistance was encountered as the device was retracted over the non medtronic guidewire.No damage was noted to the guidewire post removal of the sds.It was reported that post dilation was performed.No patient injury reported.

Manufacturer Narrative

Product analysis: the delivery system returned with a non mdt guidewire.There were numerous kinks along the hypotube.There was slight stretching of the distal shaft visible.The balloon returned deflated with crystalized residue present in the balloon and inflation lumen.There was no resistance noted when a 0.014¿ guidewire was loaded through the tip of the device and advanced proximally through the guidewire entry port.There was no deformation to the distal tip.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE INTEGRITY RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• 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: 6184800
• MDR Text Key: 62673836
• Report Number: 9612164-2016-01322
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2017
• Device Model Number: RSINT35030JX
• Device Catalogue Number: RSINT35030JX
• Device Lot Number: 0007475133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2015
• 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