MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.0/18; CORONARY DRUG-ELUTING STENT SYSTEM

Model Number 364490

Device Problem Use of Device Problem (1670)

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

Event Date 12/17/2020

Event Type  malfunction  

Manufacturer Narrative

Combination product: yes.

Event Description

An orsiro drug-eluting stent system was selected for treatment.The orsiro 3.0/18 was placed at the proximal part of the lad.Post-dilatation was performed but too much resistance was felt during re-entering the stent with a balloon for post-dilatation.

Manufacturer Narrative

Combination product: yes.The complaint instruments were not 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.In addition, the provided angiographic material was reviewed.Review of the production documentation for the product detailed above verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.During lot release inspection in the compliance test, the expanded stent outer diameter is tested for a defined amount of samples from every lot.The provided angiographic material was reviewed.The implantation of all five stents in the different target lesions in the lca is shown, partly followed by post-dilatations as not all of them are recorded.The complaint events of the difficulties in crossing the complaint stents with the balloons for post-dilatation are not visible in the angiographic material.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.

• Brand Name: ORSIRO 3.0/18
• Type of Device: CORONARY DRUG-ELUTING STENT SYSTEM
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 11499399
• MDR Text Key: 240318891
• Report Number: 1028232-2021-01272
• Device Sequence Number: 1
• Product Code: NIQ
• 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: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2022
• Device Model Number: 364490
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03200795
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1