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

Catalog Number	RSINT30018UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that the physician was attempting to use a resolute integrity device.It was a very tight calcified, lad/diag lesion.The lesion looked to be contained to mostly diag.The lesion was not pre-dilated.The first stent, a 2.75 x 18mm resolute was deployed in the diag into the lad.There was plague shift into the lad.A 3.0 x 18 mm was attempted to be deployed in the mid lad- though the diag stent.The physician reported that the stent must have got caught on the diag stent.They removed the stent and saw strut disruption.A new stent; 3.0 x 26 mm resolute integrity was advanced and deployed it in the mid lad with no issues.Both lad and diag had a great ending result.
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: 6662691
• Report Number: 9612164-2017-00798
• Device Sequence Number: 45864
• Product Code: NIQ
• UDI-Device Identifier: 00643169037151
• UDI-Public: 00643169037151
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2017

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: 03/24/2018
• Device Catalogue Number: RSINT30018UX
• Device Lot Number: 0007988945
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/26/2017
• Supplement Date Received by Manufacturer: 05/26/2017
• Initial Report FDA Received Date: 06/23/2017
• Supplement Report FDA Received Date: 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 115