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

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess performance of the resolute integrity rx drug-eluting coronary stent system.Survey results from an interventional cardiologist in practice 10 years.In the past 12 months the physician has used the resolute integrity rx drug-eluting stent 80 times.15 of the smallest (2.25 x 8 mm), 40 of the intermediate (2.25 x 12 mm to 4.00 x 24 mm) and 25 of the largest (4.00 x 30 mm) sizes were used.It was noted that in the last 12 months the medtronic resolute integrity rx drug-eluting coronary stent system was used coronary stenting procedures including those with multivessel disease, acute coronary syndrome (acs), bifurcation lesions, in-stent restenosis (isr), and total occlusions (to or cto).The following complications adverse events/effects were encountered in the using the product over the last 12 months: four death events, all related to a pre-existing condition or comorbidity.Five emergency surgery or coronary bypass events, all related to a pre-existing condition or comorbidity.Two cardiac artery perforation events, both related to the procedure but not directly to the device itself.Two shock/pulmonary edema events, both related to a pre-existing condition or comorbidity.Two cardiac artery spasm events, both related to the procedure but not directly to the device itself.The following malfunctions were also encountered in the using the product over the last 12 months: two deployment difficulties events with no impact on procedure.Two inflation difficulties events with no clinical/patient impact.Three insertion difficulties events with no impact on procedure.Four positioning difficulties events with no clinical/patient impact.It was reported that the device did not perform as expected in terms of reaching the target lesion in 5 cases due to the wrong size being chosen.It was reported that the device did not perform as expected in terms of dilation of the target lesion in 3 cases due to the stenosis being fixed.It was reported that the device did not perform as expected in terms of the ability to achieve thrombolysis in myocardial infarction (timi) flow 3 in 3 cases due to the lesion being fixed/chronic.

• 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: 10502299
• MDR Text Key: 205942241
• Report Number: 9612164-2020-03388
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2020
• 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