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

Catalog Number	RSINT22508UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/05/2019
Type of Reportable Event	Serious Injury
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 a resolute integrity coronary drug eluting stent to treat a lesion in the diagonal branch.The device was inspected with no issues noted.The device could not cross the lesion.Following removal of the delivery system, it was noted that stent dislodgement had occurred during delivery to the lesion and that the stent remained at the target lesion.The stent was crushed against artery wall at location it dislodged.No further injury reported.
Additional Manufacturer Narrative
Add'l info: an attempt was made to use a resolute integrity coronary drug eluting stent to treat a lesion in the mid lad at the first diagonal.The lad had 75% stenosis and the diagonal ostium had about 90% stenosis.There was mild calcification and no tortuosity.The lesion was pre-dilated.Resistance was noted advancing the device to the lesion.Resistance noted while retracting the stent into position.Excessive force was not used.The device did not pass through a previously deployed stent or cell of a stent.However, there was an existing non-medtronic stent in the diag, approx.3-5mm from the ostia.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis summary: several kinks were evident on the hypotube.The stent was not present on the balloon and did not return for analysis.Crimp impressions were visible on the exposed balloon surface.The balloon folds were partially expanded.The inner lumen could not be verified with a 0.015 inch mandrel most likely due to hardened blood in the guidewire lumen.Slight deformation was evident to the distal tip.No other damage was evident to the remainder of the delivery system.If information is provided in the future, a supplemental report will be issued.
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: 8490799
• Report Number: 9612164-2019-01205
• Device Sequence Number: 1724012
• Product Code: NIQ
• UDI-Device Identifier: 00643169037397
• UDI-Public: 00643169037397
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P110013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/29/2019

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: 12/10/2020
• Device Catalogue Number: RSINT22508UX
• Device Lot Number: 0009484636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 04/08/2019; 05/24/2019; 05/24/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 05/02/2019; 05/29/2019; 05/29/2019
• 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
• Patient Age: 58 YR
• Patient Weight: 117