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

Catalog Number	RSINT22512UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis summary: the stent was returned off the balloon and the device used during the procedure was not returned for analysis.Deformation was evident along the stent, with struts bunched, raised and overlapping.Crimp impressions were not confirmed as device/balloon was not returned.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician intended to use resolute integrity rx coronary drug eluting stent to treat a mildly tortuous and moderately calcified lesion located in the proximal diagonal branch exhibiting 98% stenosis.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop/tray.No issues removing the protective sheath.The device was inspected post-removal of the protective sheath with no issues identified.Negative prep was not performed.The lesion was not pre-dilated.The device did pass through a previously-deployed stent.Resistance was not encountered when advancing the device and excessive force was not used during delivery.It was reported that the stent dislodgement occurred during removal following failed delivery.There were two wires present- one with the stent, and the other with a balloon.The physician had tried to advance the 2.25x12mm resolute integrity rx coronary drug eluting stent on the diagonal wire.The balloon was on the lad wire.The stent would not pass and it then dislodged and hung up on the adjacent balloon.It was reported that there were difficulties in removing the device.The physician then removed everything, including the dislodged stent.The dislodged stent never came out of distal end of the guide.It was also reported that the physician stented the lad.The physician completed the procedure with a 2.5x12mm resolute integrity des.Patient status post procedure is alive with no 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: 7040076
• Report Number: 9612164-2017-01627
• Device Sequence Number: 1423964
• Product Code: NIQ
• UDI-Device Identifier: 00643169037403
• UDI-Public: 00643169037403
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 11/17/2017

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: 12/06/2018
• Device Catalogue Number: RSINT22512UX
• Device Lot Number: 0008405291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2017
• Initial Report FDA Received Date: 11/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1