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

Catalog Number	RSINT22518UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: kinks were evident along the hypotube.The stent had moved slightly distally on the balloon, however remained positioned between the marker bands as per specifications.There was deformation to the 8th, 9th and 10th distal stent wraps with struts raised.There was deformation to the 15th and 16th distal stent wraps with struts raised and bunched.The distal shaft was kinked 5.3cm distal to the guidewire entry port.There was deformation to the distal tip.(b)(4).
Event or Problem Description
It was reported that the physician was attempting to use a resolute integrity drug eluting stent to treat a severely calcified and mildly tortuous mid lm lesion exhibiting 98% stenosis.No damage noted to device packaging and no issues were noted when removing the devices from the hoop/tray.Negative prep was not performed.The lesion was pre-dilated.Severe calcification and possible old stent were reported as anomalies related to anatomy.During the procedure, the device did not pass through a previously deployed stent.Resistance was encountered during delivery and excessive force was used.Stent deformation occurred in vivo during positioning.The physician used another resolute to complete the procedure.No patient injury reported.

• 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: 6371376
• Report Number: 9612164-2017-00230
• Device Sequence Number: 694522
• Product Code: NIQ
• UDI-Device Identifier: 00643169037427
• UDI-Public: 00643169037427
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 02/01/2017

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: 01/31/2018
• Device Catalogue Number: RSINT22518UX
• Device Lot Number: 0007918507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2017
• Initial Report FDA Received Date: 03/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1