MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 2.5/18; CORONARY DRUG-ELUTING STENT

Model Number	401748
Medical Device Problem Codes	Material Puncture/Hole (1504); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
An orsiro drug-eluting stent system was chosen to treat a severely calcified lesion in a distal severely tortuous lad.After preparing the lesion with a rotablade and pre-dilatation the device was placed in the lesion.During inflation the balloon popped at 8 atm and the stent migrated into patients body.The stent could be retrieved.
Additional Manufacturer Narrative
Neither the complaint instrument nor the angiographic material was 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.Review of the production documentation of the last three orsiro us 2.5/18 lots that were delivered to the hospital prior to the date when the cnf was filled out verified that the instruments were manufactured according to specifications and fulfilled all the requirements of inprocess and final inspection.In addition to visual inspections each instrument is tested for air tightness by means of a helium leak test.We can therefore confirm that the instruments were delivered in a leak-proof condition.Based on the conducted investigations, no manufacturing or material related root cause could be determined.Taking into account the physicians description of the intervention and the lesion, the root cause is most likely related to the patients anatomy.

• Brand Name: ORSIRO (US) 2.5/18
• 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: 9597203
• Report Number: 1028232-2020-00264
• Device Sequence Number: 2387577
• Product Code: NIQ
• UDI-Device Identifier: 07640130439030
• UDI-Public: 07640130439030
• 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): 12/30/2019

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: 401748
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/30/2019
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 03/11/2020
• 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