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

Catalog Number	RSINT25014W
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use a resolute integrity drug eluting stent device.It is reported that the device malfunctioned and balloon would not inflate and was then pulled out; nothing detached.No patient injury is reported.
Additional Manufacturer Narrative
It was reported that the device did not inflate at all.The same inflation device was used with other devices pre and post inflation difficulties.No patient injury is reported.Device analysis: the balloon returned with blood visible in the balloon and inflation lumen.The balloon failed negative prep.On pressurisation of the device, a leak was observed on the balloon proximal cone.The balloon failed to maintain pressure.There was a short longitudinal tear on the balloon material, located at the proximal marker band.The balloon material was jagged and uneven at the tear site.Lead in scratches were evident proximal to the tear site.Deformation was also evident to the distal tip.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE INTEGRITY OTW
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7188807
• Report Number: 9612164-2018-00069
• Device Sequence Number: 13480491
• Product Code: NIQ
• UDI-Device Identifier: 00613994793317
• UDI-Public: 00613994793317
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 02/21/2018

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: 03/28/2019
• Device Catalogue Number: RSINT25014W
• Device Lot Number: 0008554880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Initial Date Received by Manufacturer: 12/20/2017
• Supplement Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 01/15/2018
• Supplement Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1