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

Catalog Number	RSINT35009UX
Medical Device Problem Codes	Difficult to Remove (1528); Device Damaged by Another Device (2915); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An attempt was made to use one resolute integrity rx coronary drug eluting stent to treat a moderately tortuous, severely calcified lesion exhibiting 95% stenosis located in the mid rca.The device was inspected with no issues.Negative prep was performed with no issues.The lesion was pre-dilated.Resistance was encountered when advancing the device.Excessive force was used during delivery.It was reported that while advancing the stent through severe calcium and a newly deployed stent, the resolute integrity encountered severe resistance inside the stent and could not advance.There were two non-medtronic guide wires in place.The device was pulled back however the stent became caught inside the previously deployed stent and possibly the second non-medtronic guide wire.The resolute integrity stent was pulled back into the guide and removed with force.It was indicated that the non-medtronic guide wire separated and wrapped on the stent balloon.It was indicated that the stent unraveled to the core wire.The patient is reported to be ali ve without injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The previously deployed stent was a resolute integrity des which was deployed during the same procedure.When the wire and guide were removed it appeared there was nothing left in the patients anatomy.The 3.5 x 9mm resolute integrity stent was not deployed.It was informed that there was no damage caused to the newly deployed resolute integrity as a result of this event.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Image review: image shows a portion of the hypotube, transitional shaft and a section of the inner member and distal shaft.There is a detachment on the distal shaft and inner member.The distal shaft material appears to be torn.There appeared to be a shadow on the image surrounding the inner member.Evaluation summary: the delivery system returned with a detachment on the distal shaft and inner member.The detached section of the delivery system and stent did not return for analysis.The remaining section of the distal shaft and inner member was stretched and torn.Stretching was evident to the transitional tubing.The support wire was not present.The material was uneven and jagged at the torn locations.No other damage was evident to the remainder of the delivery system.Additional information: the device returned with a distal portion the device missing, including the stent.The detachment occurred after the device was removed from the patient.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: 8289089
• Report Number: 9612164-2019-00363
• Device Sequence Number: 2575687
• Product Code: NIQ
• UDI-Device Identifier: 00643169037090
• UDI-Public: 00643169037090
• 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,Followup,Followup,Followup
• Report Date (Section B): 04/29/2019

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: 05/16/2019
• Device Catalogue Number: RSINT35009UX
• Device Lot Number: 0008634267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Initial Date Received by Manufacturer: 01/25/2019
• Supplement Date Received by Manufacturer: 02/21/2019; 02/21/2019; 04/16/2019
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 02/21/2019; 02/21/2019; 04/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1