MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.5/40; CORONARY DRUG-ELUTING STENT

Model Number	391239
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
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.Before the device was attached to the inflation device, it was detected that the stent was attached to the plastic cover and was not used.
Additional Manufacturer Narrative
Combination product: yes.The returned product was subjected to a detailed technical analysis and the corresponding product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.The technical investigation revealed that the stent has dislodged from the balloon but was most likely reapplied.The stent was located on the balloon between the x-ray markers in the as-returned state and could be removed from the protector together with the delivery system.The stent has clearly been expanded over its entire length.Besides of its expansion, the stent is not deformed.The balloon is not well folded anymore and shows clear signs of inflation.Stent imprints are clearly visible on the exposed balloon surface, indicating that the stent was initially crimped in between the two radiopaque markers.Contrast medium residue was observed in the inflation lumen which implies that pressure has been applied to the stent system during preparation.Review of the product release documentation confirmed that the device 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 number 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 could be determined.The root cause for the complaint event is most likely related to the handling during the preparations for the intervention, i.E.Application of pressure prior to placement of the stent across the target lesion which is warned against in the ifu.

• Brand Name: ORSIRO 2.5/40
• 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: 12579832
• Report Number: 1028232-2021-05478
• Device Sequence Number: 17120537
• Product Code: NIQ
• UDI-Device Identifier: 07640130439429
• UDI-Public: 07640130439429
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2021

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: 12/03/2022
• Device Model Number: 391239
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 11203131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Initial Date Received by Manufacturer: 10/01/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1