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

Model Number	404675
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Inflation Problem (1310)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	07/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Combination product: yes.
Event or Problem 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angio showed a recurrent radial artery perforation.A balloon was inserted to assist and eventually the catheter was withdrawn into the subclavian artery to tamponade the recurrent radial artery, which was successful.As the patient remained asymptomatic it was decided to place the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.
Additional 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
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 10996455
• Report Number: 1028232-2020-05467
• Device Sequence Number: 14387033
• Product Code: NIQ
• UDI-Device Identifier: 07640130439443
• UDI-Public: 07640130439443
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P170030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 12/12/2020
• Supplement Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention