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

Catalog Number	RSINT25030W
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 is reported that during use, the resolute integrity drug-eluting stent (des) became damaged when trying to place it in the diagonal vessel.Device was inspected prior to use , no issues noted.Lesion was pre-dilated.Resistance was noted when advancing the device and excessive force was used.The procedure was completed with another resolute des after anchoring a balloon in the lad.The balloon enabled the new stent to cross the lesion.

• 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: 6471190
• Report Number: 9612164-2017-00418
• Device Sequence Number: 10908248
• Product Code: NIQ
• UDI-Device Identifier: 00613994793270
• UDI-Public: 00613994793270
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Report Date (Section B): 03/10/2017

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: 08/19/2017
• Device Catalogue Number: RSINT25030W
• Device Lot Number: 0007697411
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2017
• Initial Report FDA Received Date: 04/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1