MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 2.25/13; CORONARY DRUG-ELUTING STENT

Model Number 401735

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

Combination product: yes.

Event Description

An orsiro drug-eluting stent system was selected for treatment of a very calcified lesion in the rca.After pre-dilatation the target lesion could not be crossed and the orsiro came off in the ostium of the rca.Eventually the stent could be retrieved by using a balloon catheter.An athrectomy was then performed.

Manufacturer Narrative

Combination product: yes.The returned product was subjected to a technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.The technical investigation of the returned instrument revealed that the balloon has clearly been inflated and contrast medium was found inside of the balloon.Stent imprints are visible on the balloon surface, indicating that the stent was initially crimped centered on the balloon.The stent was returned separately, unprotected and is severely deformed over its entire length.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.As a part of final inspection every stent system undergoes visual inspection to ensure correct embedding and homogeneous crimping of the stent.Further, the stent outer diameter is verified to 100 percent and the stent retention force of a defined amount of samples is tested from every lot.Based on the conducted investigations, no manufacturing or material related root cause could be determined.Considering the physicians description, the root cause for the complaint event is most likely related to the patients anatomy (i.E.Severely calcified lesion).

• Brand Name: ORSIRO (US) 2.25/13
• 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: 11098013
• MDR Text Key: 224528108
• Report Number: 1028232-2020-05715
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130438903
• UDI-Public: 07640130438903
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2021
• Device Model Number: 401735
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10194428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention