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

Catalog Number	RSINT30015UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis summary: the stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 12th distal stent wrap; with struts raised.Kinking was visible along the distal shaft; 4-7cm proximal to the distal tip.No deformation was evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use a resolute integrity drug eluting stent to treat a lesion.The target lesion was heavily calcified with 90% stenosis.No damage was noted to packaging.No issues were noted when removing device from hoop.The device was inspected prior to use.Negative prep was performed prior to use.The device did not pass through a previously deployed stent.No resistance was encountered when advancing the device.During an attempt to treat the lesion in the lcx using the resolute integrity drug eluting stent, the left circumflex was wired to its distal extent using a 0.014 non-medtronic wire.This was used to deliver a 3.0 x 15 sprinter balloon to the mid circumflex stenosis where a series of inflations were performed to 10 atm of pressure in order to release the lesion and prepare it for coronary stenting.An attempt was then made to deliver a 3.0 x 15 resolute des to the lesion site, however the stent would not cross the tortuous proximal circumflex which was heavily calcified, impeding stent passage.Accordingly, the stent was removed from the body and instead a 3.0 x 8 non-medtronic device was advanced to the lesion site and deployed at 14 atm of pressure.The patient status is stable.Analysis of the returned device revealed stent deformation.
Additional Manufacturer Narrative
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: 7323380
• Report Number: 9612164-2018-00476
• Device Sequence Number: 104292
• Product Code: NIQ
• UDI-Device Identifier: 00643169037502
• UDI-Public: 00643169037502
• Combination Product (Y/N): N
• 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): 04/10/2018

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: 05/26/2019
• Device Catalogue Number: RSINT30015UX
• Device Lot Number: 0008652255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Initial Date Received by Manufacturer: 02/09/2018
• Supplement Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 03/08/2018
• Supplement Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 77