MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.5/40; CORONARY DRUG-ELUTING STENT

Model Number 391020

Device Problems Entrapment of Device (1212); Failure to Deliver (2338)

Patient Problem Injury (2348)

Event Date 04/03/2019

Event Type  Injury  

Event Description

Ous mdr - an orsiro coronary drug-eluting 3.5/40 stent system was chosen to treat a severely calcified lesion in tortuous rca.It was reported that the stent was delivered but was caught at the calcification and the stent was displaced on the stent balloon.The displacement was not recognized and therefore only the distal part of the stent was expanded.During inflation the proximal part of the stent was within the guiding catheter.It was decided to withdraw the stent in the guiding catheter and to remove the entire system.During withdrawal the stent was caught at the tip of the introducer sheath, remained in the vessel and was removed by a cut down.

Manufacturer Narrative

The device was not returned to biotronik.Therefore no technical investigation on the subject could be performed.The manufacturing history was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the manufacturing history of the product detailed above did not reveal any non-conformity.During final inspection, every stent system undergoes visual inspection to ensure correct stent 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.The device in question was manufactured according to specifications and successfully passed all inprocess controls as well as the final inspection.Based on the conducted investigations no manufacturing related root cause was determined.The root cause is most likely related to to external factors during procedure.

• Brand Name: ORSIRO 3.5/40
• 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: 8591006
• MDR Text Key: 144419088
• Report Number: 1028232-2019-01847
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130439450
• UDI-Public: 07640130439450
• Combination Product (y/n): N
• PMA/PMN Number: P170030
• 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: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2020
• Device Model Number: 391020
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 08184063
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention