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

Model Number	RSINT40022UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2017
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.The 22nd and 23rd distal stent wraps were deformed with struts raised and overlapping.The inner lumen patency was verified with a 0.015 inch mandrel.The distal tip was flared.
Event or Problem Description
It was intended to use a resolute integrity drug eluting stent to treat a moderately tortuous, severely calcified distal rca lesion exhibiting 80% stenosis.The lesion was pre-dilated.There was no damage noted to packaging or issues noted when removing the device from the hoop.The device was inspected and prepped with no issues notice.There was no resistance noted when loading the device through the 6fr guide catheter however resistance was felt when advancing the device to the lesion.The device did not pass through a previously-deployed stent.It is reported that the stent failed to cross the lesion and resistance was felt when it was being removed from the body.It is indicated that this may have been due to the calcium in the vessel or the tip of the guide catheter; resistance was noted when withdrawing the device through the guide catheter.It was reported that force was used when removing the device and after removal, it was noted that the stent was damaged.The procedure was completed using a resolute integrity 4.0x18mm stent.There is no patient injury.

• 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: 6867911
• Report Number: 9612164-2017-01272
• Device Sequence Number: 890531
• Product Code: NIQ
• UDI-Device Identifier: 00643169037229
• UDI-Public: 00643169037229
• 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
• Report Date (Section B): 08/17/2017

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: 03/14/2019
• Device Model Number: RSINT40022UX
• Device Catalogue Number: RSINT40022UX
• Device Lot Number: 0008529299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2017
• Initial Report FDA Received Date: 09/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR