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

Catalog Number	RSINT30030UX
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/23/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The physician intended to implant a resolute integrity drug eluting stent in the mid left anterior descending artery.The lesion was reported to be moderately tortuous and severely calcified.It was reported that orbital atherectomy was used prior to stent deployment due to the heavy calcification of the lesion.No damage was noted to packaging, i.E.Shelf carton, hoop/tray and no issues were noted when removing the device from the hoop/tray.Negative prep was preformed with no issues.The lesion was pre-dilated.It was reported that during balloon inflation, difficulties were noted when the balloon was inflated to 9 atm.The balloon only partially inflated.It is reported that the when the catheter was removed, the physician found that the shaft had a possible hole in it.The device was not passed through a previously deployed stent.Stent was not implanted.The same inflation device was not used with other devices pre/post the inflation difficulties.Procedure was completed with another device.
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: 6499486
• Report Number: 9612164-2017-00453
• Device Sequence Number: 11173373
• Product Code: NIQ
• UDI-Device Identifier: 00643169037182
• UDI-Public: 00643169037182
• 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
• Report Date (Section B): 03/23/2017

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: 01/15/2019
• Device Catalogue Number: RSINT30030UX
• Device Lot Number: 0008448811
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/23/2017
• Supplement Date Received by Manufacturer: 03/23/2017
• Initial Report FDA Received Date: 04/18/2017
• Supplement Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR