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

Catalog Number	RSINT22512UX
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	12/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Image review: one photo was provided for review.The returned image captures the stent post removal from the patient.Stent wire wraps are visibly raised, confirming the reported stent deformation.However the reported difficulty to remove the device could not be confirmed.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 an om3 lesion with no calcification or tortuosity and with 99 % lesion stenosis.There was no damage noted to the device packaging and no issues noted when removing the device from the hoop.The device was inspected with no issues.Negative prep was not performed.The lesion was pre-dilated with two non-medtronic balloons.No difficulties were noted when loading the device onto the guidewire.The physician stated that resistance was encountered when trying to pass the stent through a previously deployed stent.Excessive force was not used.It is reported that the stent was advanced through the guide catheter and into a previously placed proximal stent when it encountered resistance.The resistance was encountered when attempting to pass the stent through the mid-distal portion of the previously deployed stent.When attempting to remove, the stent met further resistance when retracting the device over the guidewire.The physician had to remove the sds, non medtronic guide catheter and non medtronic guide extension catheter from the patient as a unit.Once the sds was removed, the physician noted that the was stent no longer on the balloon.Under fluoro, the stent was seen in the femoral sheath near hemostatic valve.The physician placed a soft angled non medtronic guidewire through the sheath and was able to pass the wire through the dislodged stent to maintain arterial access.The stent was noted to be deformed upon removal from the patient.No damage was noted to the guidewire post-removal from the patient.The physician removed the sheath with the stent in it.  the physician then placed a new sheath.The procedure was completed using a balloon angioplasty.No patient injury was reported.
Additional Manufacturer Narrative
Device evaluation: stent was returned off delivery system.Delivery system was not returned with stent for analysis.Deformation was evident to the 1-7th distal stent wraps, with struts raised, bunched and overlapping.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Image review:the returned images capture the severely stenosis lesion.Pre-dilation of the target lesion is visible in the images.The images capture a previously implanted stent immediately distal to the tip of the guide catheter.A stent is captured attempting to advance through the previously deployed stent.Deformation is visible to the proximal end of the stent.An image captures what appears to be the dislodged stent caught in the proximal end of the guide catheter.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: 7203388
• Report Number: 9612164-2018-00092
• Device Sequence Number: 164792
• Product Code: NIQ
• UDI-Device Identifier: 00643169037403
• UDI-Public: 00643169037403
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/25/2019
• Device Catalogue Number: RSINT22512UX
• Device Lot Number: 0008469803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Initial Date Received by Manufacturer: 12/20/2017
• Supplement Date Received by Manufacturer: 02/07/2018; 05/10/2018
• Initial Report FDA Received Date: 01/18/2018
• Supplement Report FDA Received Date: 03/07/2018; 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 84