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

Catalog Number RSINT27530X

Device Problems Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/21/2018

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: stretching was evident immediately proximal to the guidewire entry point to 4.7cm on the transitional tubing.The stent was not positioned on the balloon between the marker bands as per specifications, the proximal struts appear to have been pulled proximally over the marker band.Deformation was evident from the 9th to the 30th stent wraps with struts raised, bunched and overlapping.Stretching and kinks were evident on the distal shaft.No deformation was evident to the distal tip.The guidewire lumen patency could not be verified with a 0.015 inch mandrel most likely due to hardened blood.If information is provided in the future, a supplemental report will be issued.

Event Description

During the procedure, an attempt was made to use one resolute integrity drug eluting stent to treat a severely calcified lesion located in the distal left anterior descending artery, exhibiting 90% stenosis.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop.The device was inspected with no issues noted.Negative prep was performed with no issues noted.The lesion was pre-dilated.The device did not pass through a previously-deployed stent.Resistance was encountered when advancing the device.Excessive force was used during delivery.It was reported that the stent failed to cross the lesion due to use of the device in difficult lesion morphology.Procedure was completed using a non-medtronic device.Patient status post-procedure is alive with no injury.Analysis of the returned device showed that the stent was deformed.

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: 7741790
• MDR Text Key: 116090517
• Report Number: 9612164-2018-01926
• 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
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2020
• Device Catalogue Number: RSINT27530X
• Device Lot Number: 0008851848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2017
• 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: 49 YR
• Patient Weight: 78