MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 2.75/40; CORONARY DRUG-ELUTING STENT

Model Number	404674
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
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 mildly calcified pre-dilated lesion (90 percent stenosis degree) in a mildly tortuous mid lcx.The delivery balloon of the orsiro stent system did not fully expand at 8 atm.The pressure was increased up to 10 atm and the balloon fully expanded.The stent was deployed.During the second expansion the balloon could not hold the pressure.
Additional Manufacturer Narrative
Combination product: yes the returned product was subjected to a 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.The technical investigation revealed that the balloon has been inflated and was deflated in the as-returned state.A strong kink was observed in the device shaft about 8 mm distal to the guidewire exit port.Several mild kinks were observed over the entire length of the hypotube.After straightening the kinks, the balloon was successfully inflated up to 16 atm (rbp).Microscopic inspection of the instrument revealed no damage or irregularity.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.In addition to visual inspections each instrument is tested for air tightness by means of a helium leak and a pressure test.We can therefore confirm that the instrument was delivered in a leakproof condition.Based on the conducted investigations, no manufacturing or material related root cause could be determined.

• Brand Name: ORSIRO (US) 2.75/40
• 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: 12540769
• Report Number: 1028232-2021-05350
• Device Sequence Number: 13780206
• Product Code: NIQ
• UDI-Device Identifier: 07640130439436
• UDI-Public: 07640130439436
• 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): 09/15/2021

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: 10/06/2021
• Device Model Number: 404674
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 09195695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 10/21/2021
• 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