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

Catalog Number	RSINT30012UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The physician was attempting to use a resolute integrity drug eluting stent during a procedure to treat a lesion in a distal rca.Lesion was pre-dilated twice at 10 atms, max 30 secs with a euphora balloon.The resolute integrity stent was inspected prior to use with no issues noted.Resistance was encountered during advancement to the lesion.It is reported that the stent deformed.The physician used 4 another resolute integrity stents to complete the procedure.There is no patient injury.
Additional Manufacturer Narrative
The device was returned for analysis.The stent had moved distally on the balloon, and was not positioned on the balloon between the marker bands as per specifications.The most proximal stent wraps were deformed with raised struts.Crimp impressions were visible on the exposed balloon proximal surface.There was slight deformation to the distal tip.
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: 6566446
• Report Number: 9612164-2017-00585
• Device Sequence Number: 1305626
• Product Code: NIQ
• UDI-Device Identifier: 00643169037496
• UDI-Public: 00643169037496
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 06/07/2017

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: 09/12/2018
• Device Catalogue Number: RSINT30012UX
• Device Lot Number: 0008215588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2017
• Initial Date Received by Manufacturer: 04/17/2017
• Supplement Date Received by Manufacturer: 06/07/2017; 06/07/2017
• Initial Report FDA Received Date: 05/15/2017
• Supplement Report FDA Received Date: 07/03/2017; 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 76