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

Catalog Number RSINT22526X

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Device Dislodged or Dislocated (2923)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)

Event Date 06/05/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A resolute integrity rx coronary, drug eluting stent was used during a procedure to treat an emergency pci.It was reported that the device had a balloon rupture and a stent dislocation.

Manufacturer Narrative

The lesion had mild calcification.The degree of stenosis was about 70%.There was no distortion.Negative preparation was performed before use, no problems occurred.The lesion was pre-dilated.No major resistance occurred when advancing the stent to the lesion.Excessive force was not used.The device reached the lesion.It was reported that distal contrast leakage occurred on first inflation.It was reported that the device had a balloon rupture at 7 atms.The device was not moved or repositioned prior to the rupture.The balloon was not under pressure after the rupture.The stent could not be fully expanded.It was reported that the stent dislodged.An excision on the wrist was performed to attempt to remove the dislocated stent.An attempt was made to withdraw the stent with a 1.5mm balloon.The 1.5mm balloon was inflated in the stent for stent withdrawal, and the balloon and stent were pulled together.The patient has no adverse events at present.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The stent was removed from the patient.If information is provided in the future, a supplemental report will be issued.

• 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: 8874086
• MDR Text Key: 153707545
• Report Number: 9612164-2019-03292
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2020
• Device Catalogue Number: RSINT22526X
• Device Lot Number: 0009668877
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2019
• Date Device Manufactured: 09/14/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 65