MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 3.0/40; CORONARY DRUG-ELUTING STENT

Model Number 404675

Device Problems Difficult or Delayed Positioning (1157); Inflation Problem (1310)

Patient Problem Perforation (2001)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

Combination product: yes.

Event Description

Bioflow vii study: during the introduction of a guiding catheter resistance was felt and the control angio showed a recurrent radial artery perforation.A balloon was inserted to assist and eventually the catheter was withdrawn into the subclavian artery to tamponade the recurrent radial artery, which was successful.As the patient remained asymptomatic it was decided to place the orsiro stent.A underexpansion was noted after implantation and the stent was post dilated a second time.Ivus was performed and demonstrated persistent mild underexpansion.

Manufacturer Narrative

Combination product: yes.Neither the complaint instrument nor the angiographic material was returned for analysis.Therefore, no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections during which a pressure test is performed (100 percent control).Based on the conducted investigations, no manufacturing or material related root cause could be identified.

• Brand Name: ORSIRO (US) 3.0/40
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 10996455
• MDR Text Key: 221227202
• Report Number: 1028232-2020-05467
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130439443
• UDI-Public: 07640130439443
• Combination Product (y/n): Y
• PMA/PMN Number: P170030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2021
• Device Model Number: 404675
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 08191256
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention