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

Catalog Number RSINT30015X

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2017

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: sheath and stylette were loaded in device.The device returned with a detachment on the hypotube.The hypotube material was oval and jagged on both sides of the detachment site.Kinks were evident on the hypotube, proximally and distally to the detachment site.No other damage was visible to the device, including stent image review: the returned cine images capture the lesion morphology as reported by the account.Pre-dilation is carried out prior to the implantation of an unknown stent.Post dilation of the stent was performed.Another stent was implanted proximal to the initial stent implantation.The reported difficulty in crossing the lesion was not captured in the returned images.

Event Description

Physician intended to use a resolute integrity rx drug eluting stent to treat a moderately tortuous lesion in the lad with 90-95% stenosis.The device was inspected with no issues noted.Negative prep was performed with no issues.There was no damage noted to packaging.There were no issues when removing the device from the hoop/tray.The lesion was pre-dilated.The physician observed that the device had difficulty in crossing the lesion and resistance was observed when advancing the device, excessive force was not used.The procedure was completed with another resolute integrity rx drug eluting stent and there was no injury to the patient.The physician stated that the event was due to the use of the device in difficult morphology, the event was procedural related and not device related.Device analysis found a hypotube break.

• 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: 7129952
• MDR Text Key: 95670797
• Report Number: 9612164-2017-02022
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2018
• Device Catalogue Number: RSINT30015X
• Device Lot Number: 0008232300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2016
• 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: 74 YR
• Patient Weight: 77