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

Catalog Number RSINT40026X

Device Problem Device Expiration Issue (1216)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2018

Event Type  malfunction  

Event Description

A resolute integrity drug eluting stent was intended to be used to treat a moderately tortuous and calcified lesion with 70-80% stenosis in the proximal rca.There was no damage noted to the device packaging.There were no issues noted when removing the device from the hoop.The device was inspected with no issues.Negative prep was performed.The lesion was pre-dilated.Resistance was encountered when advancing the device.Excessive force was not used during delivery.It is reported that the device failed to cross the lesion and was therefore replaced with another manufacturers device.No patient injury is reported.The physician has reported that the positioning difficulties event was due to the use of the device in a difficult lesion morphology/anatomy and is not device related.The device was used 120 days beyond its expiry date.

Manufacturer Narrative

Product analysis: no packaging was returned with the device except hoop/tray, therefore confirmation of expiry date could not be performed.Protective sheath and stylette were returned loaded in device.The stent was positioned on the balloon between the marker bands as per specifications.No deformation was evident to stent wraps.No deformation was evident to the distal tip.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: no patient injury or medical/surgical intervention was required as a result of the expired product being used in the patient.The case was completed by another manufacturer¿s device.The patient¿s status post procedure was reported to be fine.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: 7224114
• MDR Text Key: 98538181
• Report Number: 9612164-2018-00155
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2017
• Device Catalogue Number: RSINT40026X
• Device Lot Number: 0007723958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2015
• 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
• Patient Age: 65 YR
• Patient Weight: 80