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

Catalog Number RSINT30026X

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2018

Event Type  malfunction  

Manufacturer Narrative

Product analysis summary: it was not possible remove the stylette. The stent had moved proximally on the balloon and was not positioned on the balloon between the markerbands as per specifications. No deformation was evident to the stent wraps. No deformation was evident to the distal tip. The inner lumen could not be verified with a mandrel due to it not being possible to remove the stylette. 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

An attempt was made to use one resolute integrity rx coronary drug eluting stent to treat a moderately tortuous, severely calcified lesion exhibiting 80% stenosis located in the proximal rca. The device was inspected with no issues. Negative prep was performed with no issues. 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 not used during delivery. It was reported that after pre-dilation the stent was sent to the lesion, however the stent could not pass through the lesion. It is 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. Displacement of the stent was seen on analysis, the stent was not positioned between the markerbands.

• Brand Name: RESOLUTE INTEGRITY RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8188638
• MDR Text Key: 131140578
• Report Number: 9612164-2018-03749
• 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

• Type of Report: Initial
• Report Date: 12/21/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/19/2018
• Device Catalogue Number: RSINT30026X
• Device Lot Number: 0008224402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial