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

Catalog Number	RSINT30022UX
Medical Device Problem Codes	Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2019
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
During a procedure an attempt was made to use a resolute integrity rx coronary, drug eluting stent to treat a moderately tortuous, moderately calcified lesion in the left anterior descending (lad) artery.Negative prep was performed.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was not used during delivery.It is reported that the stent failed to cross the lesion so it was removed from the patient.It is stated that the stent felt as though it was getting stuck inside the guide liner.It is reported that on removal of the stent it was noted to be deformed at the proximal end.The procedure was complete using the same size and model stent.It is reported that the patient is alive with no injury.
Additional Manufacturer Narrative
Product analysis summary: the stent was positioned on the balloon between the marker bands as per specifications.No stent deformation was evident.No deformation was evident to the distal tip.The inner lumen patency could not be verified with a 0.015 inch mandrel, most likely due to the presence of hardened blood in the guidewire lumen.No other damage evident to the remainder of the device.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The device was inspected prior to use.The stent looked as if it was bent back on itself on the proximal end out of the package.The stent would not go through the non-medtronic guide extension catheter (gec).It is unknown if the stent exited the tip of the gec.It was removed and not used.No intervention was required to remove the stent from the gec.No difficulties were noted when removing the stent 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: 8502827
• Report Number: 9612164-2019-01276
• Device Sequence Number: 18887629
• Product Code: NIQ
• UDI-Device Identifier: 00643169037168
• UDI-Public: 00643169037168
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P110013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2019

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: 09/12/2020
• Device Catalogue Number: RSINT30022UX
• Device Lot Number: 0009318832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 04/12/2019; 05/17/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 05/10/2019; 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1