MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.25/22; CORONARY DRUG-ELUTING STENT

Model Number	364499
Medical Device Problem Codes	Material Rupture (1546); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2021
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 lesion (90 percent stenosis degree) in a mildly tortuous distal lad.After predilatation the device was advanced to the lesion.When the balloon was inflated with nominal pressure, the pressure did not rise and blood was also observed, so it was judged that the balloon was ruptured and the catheter was removed.During withdrawal the stent has dislodged and remained in the coronary artery as confirmed by angiography.Recovery by snare was considered, but since the stent had moved slightly to distal, it was adapted to the vessel wall.A guideplus extension catheter was used during procedure.
Additional Manufacturer Narrative
Combination product: yes.The returned device was subjected to a detailed 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 revealed that the balloon shoulders are slightly unfolded, and blood was found inside of the inflation lumen and the balloon lumen.Stent imprints are visible between the x-ray markers, indicating that the stent was initially crimped on the balloon.The distal shaft shows a damage in the shape of a small cut.This cut is reaching through the wall of the shaft, causing a leakage.The leakage and the incomplete opening of the balloon most likely contributed to the dislodgement of the stent.However, the cause of the damage of the shaft could not be clarified.The stent was not returned.Review of the production documentation verified that the instrument detailed above was manufactured according to specifications.The device fulfilled all the requirements of in-process and final inspection.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.In addition to visual inspections each instrument is tested for air tightness by means of a helium leak test and a pressure test.The instrument was delivered in a leak-proof condition.Based on the conducted investigations no material or manufacturing related root cause could be identified.

• Brand Name: ORSIRO 2.25/22
• 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: 12127096
• Report Number: 1028232-2021-03824
• Device Sequence Number: 17001183
• Product Code: NIQ
• UDI-Device Identifier: 07640130439085
• UDI-Public: 7640130439085
• 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,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2021

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: 08/27/2021
• Device Model Number: 364499
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 07195707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1