MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 4.0/13; CORONARY DRUG-ELUTING STENT

Model Number	364480
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Combination product: yes.
Event or Problem Description
The orsiro drug-eluting stent system was chosen for treatment of a moderately calcified lesion (100 percent stenosis degree) in the moderately tortuous mid rca.During attempt to advance the device to the target lesion, the first bend proximal to the lesion could not be passed.After withdrawal it was noticed that the stent was dislodged.The stent was adapted to the vessel wall with a balloon.
Additional Manufacturer Narrative
Combination product: yes.The complaint instrument was not returned for analysis.Therefore, no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.In addition, the angiographic material provided was reviewed.Review of the angiographic material did not lead to any further information regarding the nature of the complaint.The films show a dislodged stent in the proximal rca.The stent is dilated with a balloon and a second stent is implanted in the target lesion.The actual complaint event is not visible in the angiographic material provided.Review of the production 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.Based on the conducted investigations no manufacturing related root cause was determined.It should be noted that, according to the corresponding ifu, pre-dilatation of the lesion is mandatory.

• Brand Name: ORSIRO 4.0/13
• 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: 11713014
• Report Number: 1028232-2021-02027
• Device Sequence Number: 3308984
• Product Code: NIQ
• UDI-Device Identifier: 07640130438958
• UDI-Public: 07640130438958
• Combination Product (Y/N): Y
• 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): 04/22/2021

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 Expiration Date: 06/29/2022
• Device Model Number: 364480
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05202737
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1