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

Catalog Number	RSINT30015UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/08/2017
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 and 15th distal stent wraps with struts raised and stretched.No deformation was evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.No other damage was evident to device.(b)(4).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 a resolute integrity drug eluting stent.The target lesion was located in the proximal left anterior descending (lad) artery which was reported to be moderately tortuous, moderately calcified with 90% stenosis (in stent re-stenosis of an overlapping non medtronic stent).No abnormalities were reported in relation to anatomy.No damage was noted to packaging and no issues noted when removing the device from the hoop/tray.The device was inspected with no issues found.Negative prep was performed with no issues.The lesion was pre-dilated using a non medtronic balloon.The device did pass through a previously-deployed stent.Resistance was encountered when advancing the device.It was reported that stent deformation occurred in vivo during positioning/advancement.The stent was pushed across the lesion with resistance.When it would not cross, the stent was removed from the patient and upon inspection it was identified that a stent strut had lifted up to a 90-degree angle.The procedure was completed using another resolute integrity which was deployed successfully and crossed the overlapping stent.There is no injury reported.
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: 6921402
• Report Number: 9612164-2017-01388
• Device Sequence Number: 19045390
• Product Code: NIQ
• UDI-Device Identifier: 00643169037502
• UDI-Public: 00643169037502
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 11/14/2017

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: 05/26/2019
• Device Catalogue Number: RSINT30015UX
• Device Lot Number: 0008652251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Initial Date Received by Manufacturer: 09/08/2017
• Supplement Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 10/06/2017
• Supplement Report FDA Received Date: 11/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 118