MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.5/35; CORONARY DRUG-ELUTING STENT

Model Number	391235
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
An orsiro drug-eluting stent system was chosen for treatment of a severely calcified lesion (98 percent stenosis degree) in a severely tortuous rca.During device introduction resistance was felt so it was decided to use a guidezilla extension catheter but still resistance was felt.Upon removal the orsiro stent system got caught at the guidezilla, the stent dislodged from balloon and was adapted to the vessel wall.
Additional Manufacturer Narrative
Only the delivery system was returned.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.The technical investigation revealed that the balloon of the complaint instrument complaint is well folded and shows no signs of inflation.Microscopic analysis of the exposed balloon surface revealed clear visible stent imprints, indicating that the stent was properly crimped in between the two radiopaque markers at the time of delivery.The stent was not returned.The angiographic material was reviewed.The actual complaint event is not visible.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all inprocess and final inspections.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, no manufacturing or material related root cause could be determined.

• Brand Name: ORSIRO 2.5/35
• 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: 10248467
• Report Number: 1028232-2020-02770
• Device Sequence Number: 14238561
• Product Code: NIQ
• UDI-Device Identifier: 07640130439368
• UDI-Public: 07640130439368
• Combination Product (Y/N): N
• 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): 07/02/2020

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: 01/29/2022
• Device Model Number: 391235
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 01202323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 08/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1