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

Catalog Number	RSINT30022UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 (3.0x22mm) to treat a severely calcified, moderately tortuous lesion with 70% stenosis in the mid lad.The lesion was pre-dilated.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop.The device was inspected with no issues.Negative prep was not performed.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 and was damaged by the calcium; on removal the physician examined the stent and it was reported to be bent.The physician felt that the tip was slightly bent from the calcification.No additional devices were required to remove the stent.The procedure was then completed using a guideliner and a longer stent, resolute integrity 3.0x38mm.There is no patient injury.The device was discarded.

• 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: 6872152
• Report Number: 9612164-2017-01291
• Device Sequence Number: 13833782
• Product Code: NIQ
• UDI-Device Identifier: 00643169037168
• UDI-Public: 00643169037168
• 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
• Report Date (Section B): 08/23/2017

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: 06/06/2019
• Device Catalogue Number: RSINT30022UX
• Device Lot Number: 0008666390
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 09/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 78