MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.5/26; CORONARY DRUG-ELUTING STENT

Model Number	364506
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2020
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 a moderately tortuous cx.During attempt to deliver guideplus ii st and the device resistance was felt and the device was removed.The stent was deformed at the proximal end.Another stent was implanted.
Additional Manufacturer Narrative
Combination product: yes.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 of the returned instrument revealed that the stent is severely deformed at its proximal end, i.E.Several struts are bent outwards.The stent is not displaced.Microscopic analysis revealed stent imprints on the exposed balloon surface, indicating that the stent was initially crimped in between the two radiopaque markers and that the bent struts were initially crimped on the balloon.The balloon is well folded and shows no signs of inflation.The tip has been manipulated, i.E.Cut in an angle.Review of the production documentation verified that the instruments were 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 could be determined.The inner diameter of the nipro guideplus st extension catheter is 1.33 mm and does therefore not meet the requirements specified in the orsiro ifu ( 0.056 inch, 1.42 mm).The root cause for the complaint event is therefore most likely related to the extension catheter which was used in the intervention.

• Brand Name: ORSIRO 2.5/26
• 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: 10733081
• Report Number: 1028232-2020-04547
• Device Sequence Number: 14315436
• Product Code: NIQ
• UDI-Device Identifier: 07640130439153
• UDI-Public: 7640130439153
• 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): 10/22/2020

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: 09/19/2021
• Device Model Number: 364506
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 09190835
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 10/26/2020
• Supplement Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1