MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.5/18; CORONARY DRUG-ELUTING STENT

Model Number	364491
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Combination product: yes.
Event or Problem Description
An orsiro drug eluting stent system was selected for treatment of a severely calcified lesion in the rca.After pre dilatation and ivus, the orsiro was attempted to be implanted, but it was difficult to deliver due to high calcification and tortuous vessel.The guiding catheter was re engaged, a guideplus was used and the orsiro was attempted to be delivered again.Thereby, it was noticed that the stent was dislodged.The stent could not be confirmed in the coronary artery and it was found near the external iliac artery.
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 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 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.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.It should be mentioned that the ifu clearly warns against reinsertion if the stent system was removed prior to expansion and not to force the passage if any resistance is felt at any time during lesion access.

• Brand Name: ORSIRO 3.5/18
• 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: 11334803
• Report Number: 1028232-2021-00807
• Device Sequence Number: 16809468
• Product Code: NIQ
• UDI-Device Identifier: 07640130439061
• UDI-Public: 7640130439061
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: P170030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2021
• Device Model Number: 364491
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05192056
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1