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

Catalog Number	RSINT22514UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	01/02/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the physician was attempting to use a resolute integrity rx drug eluting stent.No difficulties removing the protective sheath, device was inspected before use with no issues noted.Lesion was pre-dilated.Device did not pass through a previously deployed stent.Resistance was noted at the lesion, but no excessive force was used.The inflation device remained on neutral pressure during delivery of the device.It is reported that during withdrawal of the device in the vessel/guide catheter, the stent fell off the balloon and was snared successfully.No further clinical sequelae reported.
Additional Manufacturer Narrative
The target lesion was in the mid lad.The lesion had slight calcification.
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: 6306662
• Report Number: 9612164-2017-00108
• Device Sequence Number: 16222456
• Product Code: NIQ
• UDI-Device Identifier: 00643169037410
• UDI-Public: 00643169037410
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 02/10/2017

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: 05/27/2018
• Device Catalogue Number: RSINT22514UX
• Device Lot Number: 0008074692
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/09/2017
• Supplement Date Received by Manufacturer: Not provided; 02/10/2017
• Initial Report FDA Received Date: 02/07/2017
• Supplement Report FDA Received Date: 03/09/2017; 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: 82 YR
• Patient Weight: 101