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

Catalog Number	RSINT25018UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	01/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: kinks were visible on the hypotube.Visual inspection confirmed that the stent was not present on the balloon that the balloon folds were intact.Stent crimp impressions were visible on the exposed balloon surface.The distal tip was damaged.(b)(4).
Event or Problem Description
It was reported that the physician was attempting to use a resolute integrity stent to treat a slightly calcified and non-tortuous mid lad lesion.A radial approach was used.The device was not inspected prior to use.No issues noted removing the protective sheath.The lesion was pre-dilated.During the procedure, the inflation device remained on neutral pressure during delivery of the device.The device did not pass through the cell of a previously deployed stent.Resistance was encountered during delivery and very little force used.It was reported that the stent dislodged during advancement of the device.It was reported that the stent was not removed and is lodged in the ulnar vessel in the arm.It is reported that the patient is doing fine 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: 6306703
• Report Number: 9612164-2017-00111
• Device Sequence Number: 933802
• Product Code: NIQ
• UDI-Device Identifier: 00643169037373
• UDI-Public: 00643169037373
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 01/12/2017

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: 08/18/2018
• Device Catalogue Number: RSINT25018UX
• Device Lot Number: 0008184904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2017
• Initial Report FDA Received Date: 02/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 71