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

Catalog Number RSINT22518X

Device Problems Material Deformation (2976); Positioning Problem (3009); Physical Resistance/Sticking (4012)

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

Event Date 07/04/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A resolute integrity stent was attempted to be used to treat a lesion in a patient's 2nd obtuse marginal artery with no tortuosity, no calcification and 80% lesion stenosis.No abnormalities were reported in relation to the anatomy.No damage noted to packaging.No issues noted when removing the device from the hoop/tray.The device was not inspected.Negative prep was performed with no issues.The lesion was pre-dilated.Resistance was encountered when advancing the device.No excessive force was used during delivery.It was reported that stent deformation in vivo during positioning occurred.The physician completed the procedure with a non-medtronic device.It was reported that the event was due to the use of the device in difficult lesion morphology/anatomy.In addition, it was described as a difficult case, because of difficult lesion morphology of the patient.No patient injury reported.

Manufacturer Narrative

Evaluation summary: a kink was evident on the hypotube 44.5cm proximal to the distal shaft.The stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 16th distal stent wraps with struts raised.No deformation was evident to the distal tip.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: 7762193
• MDR Text Key: 116925746
• Report Number: 9612164-2018-01985
• 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: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2021
• Device Catalogue Number: RSINT22518X
• Device Lot Number: 0009029909
• 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: 08/08/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/13/2018
• 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: 75 YR
• Patient Weight: 78