MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.5/35; CORONARY DRUG-ELUTING STENT

Model Number	391018
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
An orsiro drug-eluting stent system was chosen to treat a calcified lesion in a rca.In the procedure also a guideplus was used.While inserting the orsiro resistance was felt but was delivered further.It seemed that the stent dislodged while passing the distal end of the guideplus.After removal, the stent was still on the delivery system.
Additional Manufacturer Narrative
The returned device was subjected to a detailed 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 is still well folded and shows no signs of inflation.Microscopic analysis of the 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 returned deformed and stent struts bending outwards.During procedure a nipro guideplus extension catheter was used with an inner diameter of 0.051 inch which is below the minimum diameter stated in the instruction for use (greater than or equal to 0.056 inch).Review of the manufacturing history of the product detailed above did not reveal any non-conformity.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.The device in question was manufactured according to specifications and successfully passed all inprocess controls as well as the final inspection.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 is most likely related to the extension catheter whose dimensions do not meet the requirements specified in the corresponding ifu.

• Brand Name: ORSIRO 3.5/35
• 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: 8689237
• Report Number: 1028232-2019-02324
• Device Sequence Number: 3030484
• Product Code: NIQ
• UDI-Device Identifier: 07640130439399
• UDI-Public: 07640130439399
• 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): 06/03/2019

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: 07/16/2020
• Device Model Number: 391018
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06186028
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 08/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1