MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.25/26; CORONARY DRUG-ELUTING STENT

Model Number	364505
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	06/18/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Combination product: yes.
Event or Problem Description
On (b)(6) 2021 the patient was admitted to the hospital with massive myocardial infarction.The affected vessel segment (lad, medial to distal) was treated with 2.75/26 des and post-dilated with 3.0 nc balloon.Upon dilatation, an additional more distal lesion was detected.For this treatment the affected 2.25/26 orsiro was chosen, but it was not possible to pass through the previously implanted des.During withdrawal the orsiro stent dislodged from the balloon and was adapted to the vessel wall using another balloon catheter.It was reported that the patient died several days after the procedure.According to the treating physician, the death was not device related as the patient was already in critical condition at hospital admission with massive myocardial infarction.
Additional Manufacturer Narrative
Combination product: yes.The returned product was subjected to a detailed technical analysis and the corresponding product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.In addition, a video taken from the angiographic material was reviewed.The technical investigation revealed that the balloon is well folded and shows no signs of inflation.Microscopic inspection showed stent imprints on the exposed balloon surface, indicating that the stent was initially crimped centered in between the two radiopaque markers.The stent was implanted and thus not returned for analysis.Review of the angiographic material did not lead to any further information regarding the nature of the complaint.The video shows the complaint instrument with the stent centered on the balloon.In the next sequence stent is already dislodged and adapted to the vessel wall with a balloon.Review of the product release documentation confirmed that the device was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.As a part of final inspection every stent system undergoes visual inspection to ensure correct 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 or material related root cause could be determined.The root cause for the reported complaint event is most likely related to the patients anatomy (i.E.Previously implanted stent).

• Brand Name: ORSIRO 2.25/26
• 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: 12170516
• Report Number: 1028232-2021-03974
• Device Sequence Number: 3705382
• Product Code: NIQ
• UDI-Device Identifier: 07640130439146
• UDI-Public: 7640130439146
• 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): 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/13/2022
• Device Model Number: 364505
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 04202271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 09/08/2021
• 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: Death