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

Catalog Number	RSINT25022UX
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	08/07/2017
Type of Reportable Event	Serious Injury
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
A resolute integrity drug eluting stent was used to treat a severely tortuous and severely calcified lesion in an unknown vessel.Ab normalities were reported in relation to anatomy.No damage was noted to packaging.No issues were noted when removing the device from the hoop.The device was inspected with no issues.Negative prep was performed with no issue.During delivery, resistance was en countered and excessive force was used.While attempting to place the stent, the shaft of the catheter broke in half.The device was kinked and restraightened during use.The broken half of the device was retrieved with snare.The physician took complete responsibility for the shaft breaking.The physician repeatedly pushed and pulled very hard and rough on the catheter while attempting to deliver the device.The physician reported that it was a very difficult case, and not a product failure.The stent was implanted.Patient health status post procedure is alive, fine, and no injury.

• 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: 6903283
• Report Number: 9612164-2017-01347
• Device Sequence Number: 717775
• Product Code: NIQ
• UDI-Device Identifier: 00643169037380
• UDI-Public: 00643169037380
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P110013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/05/2019
• Device Catalogue Number: RSINT25022UX
• Device Lot Number: 0008615656
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention