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

Catalog Number	RSINT22530UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	10/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The physician intended to use a resolute integrity drug eluting stent to treat a lesion exhibiting moderate tortuosity, moderate calcification and 90% stenosis.The lesion was situated in the mid/distal lad.There were no abnormalities reported in relation to anatomy.There was no damage noted to device packaging and no issues noted when removing the device from the hoop/tray.No issues were encountered when removing the protective sheath.The device was inspected post-removal of the protective sheath with no issues.Negative prep was performed with no issues noted.The lesion was pre-dilated.The inflation device remained on neutral pressure during delivery of the device.Resistance was encountered when advancing the device and excessive force was not used.It was noted that the stent would not advance through previously deployed stents to the distal lesion.When it was realised that the stent would not advance any further, the stent was pulled back for removal.The stent subsequently dislodged, and was not removed.Post-dislodgement, a balloon was used to crush the dislodged stent up against the mid lad vessel wall.No further patient injury was reported post procedure.

• 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: 7058417
• Report Number: 9612164-2017-01670
• Device Sequence Number: 19172003
• Product Code: NIQ
• UDI-Device Identifier: 00643169037335
• UDI-Public: 00643169037335
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P110013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/27/2017

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: 06/08/2019
• Device Catalogue Number: RSINT22530UX
• Device Lot Number: 0008669537
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2017
• Initial Report FDA Received Date: 11/27/2017
• 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