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

Catalog Number RSINT25026X

Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis:the device returned with a detachment on the hypotube 57cm distal to the strain relief.The hy potube material was oval and jagged on both sides of the detachment site.Kinks were evident on the hypotube both proximal and distal to the detachment site.The stent was not positioned between the markerbands as per specification.Proximal struts were positioned over the proximal markerband.Deformation was evident to the 1st, 2nd distal wraps.No deformation was evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.No other damage evident to the remainder of the device.If information is provided in the future, a supplemental report will be issued.

Event Description

During a procedure, an attempt was made to use one resolute integrity rx coronary drug eluting stent to treat a mildly tortuous, severely calcified lesion exhibiting cto (chronic total occlusion-100%) located in the proximal left anterior descending (lad) artery.The device was inspected with no issues noted.Negative prep was performed with no issues noted.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 used during delivery.It was reported that the stent failed to cross the lesion due to excessive calcification.It was stated that the event was due to use of the device in difficult lesion morphology/anatomy, i.E.The event was procedural related and not device related.It was later reported that stent deformation and hyoptube detachment occurred when attempting to cross the lesion.The patient was reported to be alive with no injuries.

• Brand Name: RESOLUTE INTEGRITY RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 10539959
• MDR Text Key: 207121364
• Report Number: 9612164-2020-03472
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2022
• Device Catalogue Number: RSINT25026X
• Device Lot Number: 0009864305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2020
• Date Device Manufactured: 01/29/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 91 YR
• Patient Weight: 78