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

Catalog Number RSINT30018UX

Device Problems Failure to Advance (2524); 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 07/02/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A 3.00 x 18 mm resolute integrity drug eluting stent was intended to be used to treat a severely tortuous and heavily calcified lesion in the proximal 1st om.Stenosis was 98%.No abnormalities were reported in relation to anatomy.No damage was noted to packaging.No issues were noted when removing the device from the hoop.The device was inspected.Negative prep was performed.The lesion was pre-dilated with both euphora and nc euphora balloons multiple times.The device did not pass through a previously-deployed stent.Resistance was encountered when advancing the device.Excessive force was not used during delivery.The device failed to cross the lesion despite multiple attempts.The device was re-inserted multiple times.The pre-dilation balloons were used repeatedly after failed attempts to insert the stent.It was reported that stent deformation occurred.The distal end of the stent was mangled.The procedure was successfully completed using a 3.0x22mm resolute integrity stent and a 3.00 x 12 mm resolute integrity stent.No patient injury is reported.

Manufacturer Narrative

Product analysis summary: still cine images were received from the account.The images captured the lesion site in the ob with calcification and stenosis evident.A still cine image also captured what appears to be the ob after treatment, however there were no images capturing the treatment of the vessel.The stent deformation in vivo during positioning therefore cannot be confirmed from the still cine images provided.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: 7731017
• MDR Text Key: 115674024
• Report Number: 9612164-2018-01886
• Device Sequence Number: 0
• Product Code: NIQ
• Reporter Country Code: US
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: RSINT30018UX
• Device Lot Number: 0008657150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 05/31/2017
• 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: 58 YR