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

Catalog Number RSINT30030X

Device Problem Material Deformation (2976)

Patient Problems Calcium Deposits/Calcification (1758); No Consequences Or Impact To Patient (2199); Stenosis (2263)

Event Date 07/11/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A resolute integrity drug eluting stent was intended to be used during a procedure.The intended lesion was located in the proximal lad, with no tortuosity, severe calcification, and 90% stenosis.There was no damage noted to packaging, and no issues when removing the device form the hoop.The device was inspected, and negative prep performed with no issues.The lesion was pre-dilated, the device did not pass through a previously deployed stent.Resistance was encountered when advancing the device but no excessive force was used.It is reported that stent deformation occurred in vivo during positioning.It is noted that the event was due to the use of the device in difficult lesion morphology.No patient injury is reported.

Manufacturer Narrative

Device evaluation: there was a kink on the hypotube 10.6cm distal to the strain relief.Transition tubing was deformed appearing torn from the guidewire entry port towards the distal shaft.The distal shaft outer material and guidewire lumen were torn and the material was jagged.Support wire was exposed and there were two kinks on the distal shaft 27.2cm and 27.8cm proximal to the distal tip.The stent was positioned on the balloon between the marker bands as per specifications.No deformation was evident to the stent wraps.No deformation was evident to the distal tip.The 0.015 inch mandrel could not load through the guidewire lumen due to hardened blood in the guidewire lumen.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: 7721584
• MDR Text Key: 115376108
• Report Number: 9612164-2018-01863
• 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,Followup,Followup,Followup
• Report Date: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2018
• Device Catalogue Number: RSINT30030X
• Device Lot Number: 0008149556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2016
• 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: 60 YR