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

Catalog Number	RSINT30009UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2017
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 calcified lesion in the rca with a previous deployed des.No damage noted to device packaging.Device was inspected prior to use no issues noted.Negative prep was performed followed by neutral prep.Lesion was pre-dilated.Resistance was encountered when advancing the device past a just deployed resolute, excessive force was not used.Physician was unable to deploy the stent and when the physician pulled it back into the 6f guideliner, he noticed under fluoro, that the stent slipped off the balloon.He then removed the guideliner and the stent without any issue to the patient.He successfully deployed a resolute immediately afterwards.Physician insists that there was no issue with the resolute integrity.
Additional Manufacturer Narrative
Stop cock returned attached to luer.Kinks were visible on the hypotube and distal shaft.Visual inspection confirmed that the stent was not present on the balloon.Stent crimp impressions were visible on the exposed balloon surface.Dislodged stent was returned, and deformation could be seen to the stent wraps at one end of the stent.The distal tip was damaged.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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: 6459553
• Report Number: 9612164-2017-00359
• Device Sequence Number: 13601093
• Product Code: NIQ
• UDI-Device Identifier: 00643169037489
• UDI-Public: 00643169037489
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/13/2017

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: 10/04/2018
• Device Catalogue Number: RSINT30009UX
• Device Lot Number: 0008244005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2017
• Initial Date Received by Manufacturer: 03/07/2017
• Supplement Date Received by Manufacturer: Not provided; 05/13/2017
• Initial Report FDA Received Date: 04/05/2017
• Supplement Report FDA Received Date: 06/07/2017; 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1