MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDEAVOR RESOLUTE 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 endeavor resolute rx coronary drug-eluting stent.Survey results from an interventional cardiologist in practice 15 years.In the past 12 months, the physician has used the endeavor resolute stent 100 times.30 of the smallest (2.25 x 8 mm), 60 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 device was used in other non-coronary procedures including 20 devices that used to treat the lower leg-pta and 10 used to treat the renal arteries- pta.The following device complaints were encountered in procedure when using the endeavor resolute product over the last 12 months: it was reported that in five cases the device did not perform as expected in terms of reaching the target lesion due to the presence of a calcified and angulated stenosis.It was reported that the in five cases the device did not perform as expected in terms of dilation of the target lesion.It was stated that this was due to the presence of calcified and circular stenosis.It was also reported that in ten cases the device did not perform as expected in terms of ability to achieve thrombolysis in myocardial infarction (timi) flow 3, due to the presence of a micro-vascular obstruction.No patient injury was reported.

Manufacturer Narrative

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.

• Brand Name: ENDEAVOR RESOLUTE RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10257676
• MDR Text Key: 198330029
• Report Number: 9612164-2020-02533
• 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: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 07/10/2020
• Supplement Dates Manufacturer Received: 06/22/2020
• Supplement Dates FDA Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1