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

Catalog Number	RSINT40022UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/03/2017
Type of Reportable Event	Malfunction
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, 3rd and 4th distal stent wraps with struts raised and overlapping.Slight deformation was evident to the distal tip.The inner lumen patency was verified.Contrast was visible throughout the inner lumen.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 resolute integrity rx drug eluting stent to treat a non-tortuous and severely calcified lesion located in the proximal right coronary artery, exhibiting 99% stenosis.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging and no issues noted when removing the device from the hoop/tray.The device was inspected and negative prep was performed with no issues noted.The lesion was pre-dilated.The device did not pass through a previously-deployed stent.Resistance was encountered when advancing the device and excessive force was not used during delivery.It was reported that the stent deformation occurred in-vivo during positioning.It was described that the lesion was pre-dilated using a medtronic device (euphora 3.0 x 15) and then the stent wouldn't cross lesion.The physician pulled out sds and inserted a non medtronic guide extension catheter.It was informed that the physician tried to pass stent through the non medtronic guide extension catheter, but stent wouldn't go through the device completely.The sds was pulled out and the stent was inspected; the stent was damaged, the proximal part of stent was flared open and frayed.The physician completed the procedure with a non medtronic stent with no more dilation required.Patient status post-procedure is alive with no injury.

• 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: 7127922
• Report Number: 9612164-2017-02004
• Device Sequence Number: 2145113
• Product Code: NIQ
• UDI-Device Identifier: 00643169037229
• UDI-Public: 00643169037229
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/19/2017

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: 09/01/2018
• Device Catalogue Number: RSINT40022UX
• Device Lot Number: 0008201195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 12/19/2017
• 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