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

Catalog Number	RSINT30012UX
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product evaluation summary: the sheath and stylette were not returned with the device.There was a detachment on the hypotube 61cm distal to the strain relief.Kinks were evident on the hypotube 4.5cm proximal and 12cm distal to the detachment site.The hypotube material was oval and jagged on both sides of the detachment site.There was no stretching evident to the distal shaft, proximal balloon bond or tip.There was no other damage evident to the remainder of the device.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During a procedure an attempt was made to use a resolute integrity rx coronary drug eluting stent to treat a mildly tortuous, non calcified proximal right coronary artery (rca).Some resistance was noted when removing the stylette.The device was inspected with no issues.Negative prep was not performed.The device returned with a detachment on the hypotube.As the stent was being advanced, resistance was felt, but advancement was continued.At that time the catheter broke.It was reported that the detachment occurred outside of the body.They were able to remove and use another new stent.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: 9212920
• Report Number: 9612164-2019-04432
• Device Sequence Number: 19378412
• Product Code: NIQ
• UDI-Device Identifier: 00643169037496
• UDI-Public: 00643169037496
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/21/2019

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: 03/19/2021
• Device Catalogue Number: RSINT30012UX
• Device Lot Number: 0009652408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 10/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 68