MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 2.5/13; CORONARY DRUG-ELUTING STENT

Model Number	401736
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2020
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.The lesion could not be crossed and the device was removed.When the device was ready to load again it was discovered that there was no stent on the balloon.The stent was found in the co-pilot hemostatic valve.
Additional Manufacturer Narrative
Combination product: yes.Initially lot 03196537 was reported.However, an instrument with lot 09195104 was returned for analysis together with a copilot valve and a sterile pouch showing lot 03196537.It is assumed that the returned instrument is the actual complaint instrument.No further information could be obtained by the local staff.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 balloon has been inflated and was deflated in the as-returned condition.Microscopic analysis revealed stent imprints on the exposed balloon surface, indicating that the stent was initially crimped in between the two radiopaque markers.The stent was not returned for analysis.A reference stent system was successfully introduced and withdrawn through the returned copilot valve.Review of the manufacturing documentation of the product detailed above did not reveal any non-conformity.During final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 in-process 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.It should be noted that the ifu warns the user against reinsertion if the stent system was removed prior to expansion.

• Brand Name: ORSIRO (US) 2.5/13
• 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: 10759566
• Report Number: 1028232-2020-04710
• Device Sequence Number: 16428817
• Product Code: NIQ
• UDI-Device Identifier: 07640130438910
• UDI-Public: 07640130438910
• 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,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2020

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: 10/07/2021
• Device Model Number: 401736
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 09195104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 11/20/2020
• 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
• Patient Age: 65 YR