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

Catalog Number	RSINT27518UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
An attempt was being made to use a resolute integrity drug eluting stent in a heavily calcified lad lesion.The device was inspected before use and no issues were reported.The lesion was pre-dilated.Resistance was not noted while getting to the lesion and excessive force was not used.When advancement became a little harder the device was retracted.Stent deformation was then noticed.The procedure was completed using another stent.No patient injury reported.
Additional Manufacturer Narrative
Review of cine images received: the images capture calcified lesion sites in the lad as reported by the account.Pre-dilation is visible from the images by an unidentified balloon.There are no images capturing the attempted delivery and subsequent removal of the resolute integrity 2.75 x 18mm device.The images show the delivery and successful deployment of numerous unidentified stents along the length of the vessel.Product analysis: the stent delivery system was returned to medtronic for evaluation.On review the stent was positioned on the balloon between the marker bands as per specifications.There was deformation to the first distal stent wrap with struts raised.There were kinks along the distal shaft 9.2cm and 21.4cm distal to the guidewire entry port.There was deformation to the distal tip.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 6188377
• Report Number: 9612164-2016-01330
• Device Sequence Number: 1025465
• Product Code: NIQ
• UDI-Device Identifier: 00643169037564
• UDI-Public: 00643169037564
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 02/07/2017

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: 05/12/2018
• Device Catalogue Number: RSINT27518UX
• Device Lot Number: 0008052334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2016
• Supplement Report FDA Received Date: 02/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 83