MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 3.0/15; CORONARY DRUG-ELUTING STENT

Model Number	401744
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2021
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 of a severely calcified lesion in a moderately tortuous mid rca.A 2nd orsiro was introduced.After multiple attempts to cross the lesion the stent was removed and while wiping down the catheter it was noticed that the stent had slipped off the balloon.It was still on the distal portion of the catheter.A 6 f guideliner was used during procedure.The first second device is reported separately.
Additional Manufacturer Narrative
Combination product: yes.The device lot number and size was not included on original reported.It has been added to this report.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 displaced by about 8 mm in proximal direction.The stent is deformed at its distal end, i.E.Few struts are bent outwards.Stent imprints on the exposed balloon surface indicate the stent was initially crimped in between the two radiopaque markers.The balloon is well folded and shows no signs of inflation.Review of the production documentation for the product detailed above verified that the instrument 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 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.

• Brand Name: ORSIRO (US) 3.0/15
• 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: 11255140
• Report Number: 1028232-2021-00547
• Device Sequence Number: 3977012
• Product Code: NIQ
• UDI-Device Identifier: 07640130438996
• UDI-Public: 07640130438996
• Combination Product (Y/N): Y
• 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,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2021

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 Model Number: 401744
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 04200674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 01/29/2021
• Supplement Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization