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

Catalog Number	RSINT25022UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The physician was attempting to use a resolute integrity drug eluting stent to treat a lesion in the proximal circumflex.The lesion is reported to have moderate tortuosity, severe calcification and 90% stenosis.No anatomical abnormalities were reported.No damage was noted to the device packaging and no issues were noted when removing the device from the hoop.The device was inspected and negative prep was performed prior to use with no issues noted.The lesion was pre-dilated.The device did not pass through any previously deployed stent.Resistance was encountered when advancing the device however no excessive force was used.The resolute stent was unable to cross the lesion and stent dislodgement occurred following failed delivery.The stent was successfully removed using a snare.The stent dislodgement was attributed to the presence of significant calcium.Surgery was completed successfully.No injury is reported to have occurred to the patient.
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: 6232237
• Report Number: 9612164-2017-00021
• Device Sequence Number: 13717554
• Product Code: NIQ
• UDI-Device Identifier: 00643169037380
• UDI-Public: 00643169037380
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Report Date (Section B): 12/12/2016

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: 08/19/2017
• Device Catalogue Number: RSINT25022UX
• Device Lot Number: 0007697429
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2016
• Supplement Date Received by Manufacturer: 12/12/2016
• Initial Report FDA Received Date: 01/09/2017
• Supplement Report FDA Received Date: 09/28/2017
• 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
• Patient Age: 70 YR