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 coronary drug-eluting stent.Survey results from an interventional cardiologist in practice 20 years.In the past 12 months, the physician has used the resolute integrity stent 50 times.15 of the smallest (2.25 x 8 mm), 30 intermediate (2.25 x 12 mm to 4.00 x 34 mm) and 5 of the largest sizes (4.00 x 38 mm) of these stents were used.It was noted that the device was usedin other non-coronary procedures including 10 that were used for the treatment of chronic closures, 1 used for the treatment of congestion, 10 for the treatment of dissections and 5 for the treatment of restenosis.The following device complaints were encountered in procedure when using the resolute integrity product over the last 12 months: 2 events in which deployment difficulties occurred, both of which had no clinical/patient impact.It was reported that the device did not perform as expected in terms of reaching the target lesion in 2 events due to winding and calcified lesions.It was also reported that the device did not perform as expected in terms of dilation of the target lesion in 2 events.It was stated that this was due to the low susceptibility of the calcified lesion.No patient injury was reported.

Manufacturer Narrative

Additional information: the physician in this case consented to participate in the survey but did not consent to be contacted regarding the information provided and wished to remain anonymous, therefore information for facility and city cannot be provided.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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
• MDR Report Key: 10251766
• MDR Text Key: 198315341
• Report Number: 9612164-2020-02509
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/14/2020

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
• Date Manufacturer Received: 06/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1