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

Model Number 391020

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 02/23/2021

Event Type  Injury  

Manufacturer Narrative

Combination product: yes.

Event Description

An orsiro drug-eluting stent system was selected for treatment of a severely calcified pre-dilated lesion (90 percent stenosis degree) at the bifurcation of the left coronary vessel.During the attempt to position the orsiro stent inside the lesion, the stent dislodged from the delivery balloon.After that the guidewire was used to pull the stent near the access site.Finally, the artery was opened via surgery and stent was removed.

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.In addition, the provided angiographic material was reviewed.The technical investigation of the returned instrument revealed that the balloon is not well folded anymore and shows signs of inflation.Stent imprints are visible on the balloon surface, indicating that the stent was initially crimped centered in between the two radiopaque markers.The stent was returned separately wrapped in a thin cloth.The stent is severely deformed over its entire length.The provided angiographic material was reviewed.A stent system proximal to the target lesion visible with a deformed proximal stent end direct at the distal end of the guiding catheter.The crossing attempt and the actual complaint event is not visible.The angiographic material does therefore not provide further relevant information regarding the root cause of the complaint.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.

• 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: 11637683
• MDR Text Key: 244609242
• Report Number: 1028232-2021-01703
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130439450
• UDI-Public: 07640130439450
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2022
• Device Model Number: 391020
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 02201847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Initial Date Manufacturer Received: 04/08/2021
• Initial Date FDA Received: 04/08/2021
• Supplement Dates Manufacturer Received: 06/01/2021
• Supplement Dates FDA Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1