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

Catalog Number	RSINT25014UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician was attempting to use a resolute integrity rx drug eluting stent to treat a moderately calcified and severely tortuous distal cx lesion exhibiting 85% stenosis.The patient's anatomy was described as multiple large angle turns with calcium and tortuous.No damage was noted to device packaging.The device was inspected and negative prep performed with no issues noted.The device was pre-dilated.During the procedure the device passed through a previously deployed stent.Resistance was encountered when advancing the device and no excessive force used.It was reported that stent deformation in vivo during positioning occurred.It was reported that the stent was damaged in the middle od of the stent.No patient injury was reported.As the physician was concerned that there was an issue with the stent then a 2.5 x 8mm resolute integrity stent was then selected and used to complete the procedure with no issues.
Additional Manufacturer Narrative
Correction: section: the lesion was pre-dilated image review: the returned image captures the cx lesion confirming the patient morphology.The image does not capture the reported stent deformation.Evaluation summary: the stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 1st, 4th 7th 8th and 9th distal stent wraps with struts raised and overlapping.Slight deformation was evident to the distal tip.(b)(4).

• Brand Name: RESOLUTE INTEGRITY RX
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7209742
• Report Number: 9612164-2018-00124
• Device Sequence Number: 1185335
• Product Code: NIQ
• UDI-Device Identifier: 00643169037366
• UDI-Public: 00643169037366
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P110013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/29/2019
• Device Catalogue Number: RSINT25014UX
• Device Lot Number: 0008653904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2018
• Initial Date Received by Manufacturer: 01/16/2018
• Supplement Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 01/22/2018
• Supplement Report FDA Received Date: 03/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR