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

Catalog Number	RSINT27526UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: device was returned for evaluation.Kinks were evident along the hypotube.The most proximal stent wraps were intact on the balloon.The remaining mid to distal stent wraps were stretched distally off the balloon, bunched and deformed.Crimp impressions were visible on the exposed mid to distal balloon surface.A 0.015inch mandrel could not be loaded through the inner lumen due to hardened blood/residue.(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use a resolute integrity drug eluting stent to treat a lesion located in the mid left anterior descending (lad) artery.The target lesion was reported to be moderately tortuous, severely calcified with 90% stenosis.No damage was noted to packaging and no issues were noted when removing the devices from the tray/hoop.The device was inspected with no issues identified.Negative prep was also performed with no issues.The device was not kinked or restraightened during use.The lesion was predilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device but excessive force was not used.It was reported that the stent was unable to cross the lesion.Upon removal of the stent the doctor said he felt some resistance.The physician could not tell if the tip was fractured, he inspected closely.It was observed when the stent was outside the guide that it had unraveled.It stayed on the balloon and did not dislodge through the system.Procedure was completed with another device.No patient injury was 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: 6645985
• Report Number: 9612164-2017-00767
• Device Sequence Number: 19159106
• Product Code: NIQ
• UDI-Device Identifier: 00643169037465
• UDI-Public: 00643169037465
• 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): 05/19/2017

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: 09/05/2018
• Device Catalogue Number: RSINT27526UX
• Device Lot Number: 0008206954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Initial Date Received by Manufacturer: 05/19/2017
• Supplement Date Received by Manufacturer: 05/19/2017
• Initial Report FDA Received Date: 06/16/2017
• Supplement Report FDA Received Date: 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 112