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

Model Number	RSINT25018UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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 intended to use a resolute integrity drug eluting stent to treat a lesion located in the mid obtuse marginal (om) which was severely tortuous and severely calcified.No damage noted to packaging, i.E.Shelf carton, hoop/tray and no issues were noted when removing the device from the hoop.The device was inspected with no issues identified.Negative prep was performed with no issues encountered.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.It was reported that when the stent was being positioned in the target lesion, one of the struts appeared to catch some of the calcification and when pushed became deformed.The physician did complete the procedure.The same size/model stent was used.
Additional Manufacturer Narrative
Evaluation summary: the stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 1st, 2nd and 3rd distal stent wraps with struts raised.Slight deformation was evident to the distal tip.A kink was visible on the distal shaft of the device at 17cm proximal to the distal tip.The inner lumen patency was verified.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: 6851230
• Report Number: 9612164-2017-01235
• Device Sequence Number: 11069631
• Product Code: NIQ
• UDI-Device Identifier: 00643169037373
• UDI-Public: 00643169037373
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 11/29/2017

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: 01/25/2019
• Device Model Number: RSINT25018UX
• Device Catalogue Number: RSINT25018UX
• Device Lot Number: 0008469807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Initial Date Received by Manufacturer: 08/11/2017
• Supplement Date Received by Manufacturer: 11/02/2017
• Initial Report FDA Received Date: 09/08/2017
• Supplement Report FDA Received Date: 11/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR