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

Catalog Number	RSINT22512UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Delivery system was returned attached to three-way valve and with guide catheter.Numerous kinks were visible along the hypotube.The stent was not present on the balloon and did not return for analysis.A 0.035inch guidewire was loaded through the guide catheter to ensure the stent wasn¿t returned.Crimp impressions were visible on the exposed balloon surface.The balloon folds remained intact.Deformation was apparent to the distal tip.The inner lumen patency was verified.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was intending on implanting a resolute integrity drug eluting stent into a patient.No damage was noted to the packaging nor were there any issues noted when removing the device from the hoop/tray.The protective sheath was present on the stent after it was removed from the hoop and there were no difficulties removing the sheath.The device was inspected and negative prep was performed with no issues.It was reported that the stent slipped while loading through the haemostatic valve.The stent came off the balloon distal to the haemostatic valve.The account noted that the stent was hard to track through the guide catheter so the physician pulled back the delivery system and observed that stent slippage had occurred in the guide.The physician changed out the guide catheter and rewired the vessel and put in new stent.The device was replaced with a medtronic product and no injuries were 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: 7214632
• Report Number: 9612164-2018-00134
• Device Sequence Number: 16176821
• Product Code: NIQ
• UDI-Device Identifier: 00643169037403
• UDI-Public: 00643169037403
• 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): 01/24/2018

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: 01/29/2019
• Device Catalogue Number: RSINT22512UX
• Device Lot Number: 0008473260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2018
• Initial Report FDA Received Date: 01/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 113