MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.25/13; CORONARY DRUG-ELUTING STENT

Model Number	401735
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
An orsiro drug-eluting stent system was chosen to treat a moderate calcified lesion in a mildly tortuous coronary vessel.The stent in question was inadvertently being passes through an existing stent side branch.This existing stent had been placed 3 days earlier, it was not very visible.When the affected stent was placed in the coronary vessel and pulled back it may have snagged up against the previously placed stent and it forced the stent to slide off the balloon.
Additional Manufacturer Narrative
The returned product was subjected to a technical analysis and the corresponding production documentation was reviewed.The delivery system was returned for analysis.The technical investigation revealed that the balloon of the complaint instrument is still well folded and shows no signs of inflation.Microscopic analysis showed clearly visible stent embedding traces on the balloon surface, indicating that the stent was properly crimped between the two radiopaque markers at the time of delivery.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process 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.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 was determined.Taking the physicians post-interventional review of the angiographic material into consideration, it seems likely that the root cause for the complaint event is related to patients anatomy (i.E.Crossing of previously placed stent).

• Brand Name: ORSIRO 2.25/13
• 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: 8622530
• Report Number: 1028232-2019-01996
• Device Sequence Number: 2260627
• Product Code: NIQ
• UDI-Device Identifier: 07640130438903
• UDI-Public: 07640130438903
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P170030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2019

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 Model Number: 401735
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 09184428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Received by Manufacturer: 05/10/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 05/19/2019
• 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