MAUDE Adverse Event Report: MEDTRONIC CARDIOVASCULAR SANTA ROSA DRUG FILLED STENT DFS; STENT, CORONARY, DRUG-ELUTING

Catalog Number DFS30026X

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2015

Event Type  malfunction  

Manufacturer Narrative

No pma / 510(k), pre-market study device.If information is provided in the future, a supplemental report will be issued.

Event Description

During a procedure a polymer free dfs coronary drug-eluting stent was used to treat a lesion.It was reported that the proximal part of the stent was observed to have malapposed on the original post stenting oct.The stent had been deployed at 16 atms and post dilated at 20 atms.The stent was post-dilated a second time to correct the malapposition of the proximal part of the stent.A small distal edge dissection was then noted on a repeat oct after the second post-dilation of the stent.It is stated that the dissection was not related to use of a medtronic device.It was stated that no further angiography was performed.

Manufacturer Narrative

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

• Brand Name: DRUG FILLED STENT DFS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC CARDIOVASCULAR SANTA ROSA; 3576 unocal place; santa rosa CA 95403
• Manufacturer (Section G): MEDTRONIC CARDIOVASCULAR SANTA ROSA; 3576 unocal place; santa rosa CA 95403
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9737801
• MDR Text Key: 190808292
• Report Number: 2953200-2020-00005
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2016
• Device Catalogue Number: DFS30026X
• Device Lot Number: V06113806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2020
• Date Device Manufactured: 05/19/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 72