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

Device Problems Burst Container or Vessel (1074); Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)

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 coronary drug-eluting stent.Survey results from an interventional cardiologist in practice 7 years.In the past 12 months, the physician has used the resolute integrity stent 300 times.40 of the smallest (2.25 x 8 mm), 250 intermediate (2.25 x 12 mm to 4.00 x 34 mm) and 10 of the largest sizes (4.00 x 38 mm) of these stents were used.It was noted that the 5 devices were used in other non-coronary procedures to treat other arteries.The following complications adverse events/effects were encountered in the using the resolute integrity product over the last 12 months: four incomplete stent apposition events, all related to the procedure but not directly to the device itself.The following device complaints were encountered when using the resolute integrity product over the last 12 months: two events in which a burst balloon occurred.Both events reportedly had no clinical/patient impact.Two events in which detachment of component(s) (in vivo) occurred.Both events reportedly also had no clinical/patient impact.It was reported that the device did not perform as expected in terms of reaching the target lesion in 10 events because the lesion was unreachable due to calcification and strong kinking.It was also reported that in 5 events the device did not perform as expected in terms of dilation of the target lesion.It was stated that the lesion could not be sufficiently expanded due to massive calcification.

• 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: 10249427
• MDR Text Key: 198312925
• Report Number: 9612164-2020-02495
• 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: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• 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: 06/22/2020
• 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