MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 3.5/40; CORONARY DRUG-ELUTING STENT

Model Number	404676
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2021
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 mildly calcified pre-dilated lesion in the mildly tortuous lad.The orsiro was delivered to the lesion, but it would not inflate.The inflation device was replaced, but the balloon would still not inflate.A different orsiro was used with no problems.
Additional Manufacturer Narrative
Combination product: yes.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 not been inflated but both balloon shoulders are slightly unfolded.The stent is also slightly opened at both ends.Microscopic inspection revealed a constriction of the outer shaft at the proximal balloon weld.A reference transportation wire could not be introduced into the guidewire lumen of the instrument whereas it was possible to fully introduce a reference 0.014 inch guidewire.The findings indicate that the shaft deformations were most likely caused by a tensile force which has been applied to the distal part of the instrument, possibly during removal of the transportation wire.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all inprocess and final inspections.In addition to visual inspections each instrument is inflated and tested for air tightness by means of a helium leak test.Based on the conducted investigations, no manufacturing or material related root cause could be determined.The root cause for the complaint event is most likely related to the handling during the preparations for the intervention.It should be noted that, according to the ifu, the user is advised to exercise care during device handling to reduce the possibility of accidental breakage, bending, kinking of the stent system shaft.

• Brand Name: ORSIRO (US) 3.5/40
• 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: 11348507
• Report Number: 1028232-2021-00844
• Device Sequence Number: 2564613
• Product Code: NIQ
• UDI-Device Identifier: 07640130439450
• UDI-Public: 07640130439450
• 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): 01/26/2021

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: 08/28/2021
• Device Model Number: 404676
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 08190979
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/26/2021
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 04/26/2021
• 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
• Patient Age: 66 YR