MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.0/40; CORONARY DRUG-ELUTING STENT

Model Number 391241

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/02/2020

Event Type  malfunction  

Manufacturer Narrative

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 stent is severely deformed at its distal end, i.E.Several struts are bent outwards.The stent is not displaced.Microscopic analysis revealed stent imprints on the exposed balloon surface, indicating that the stent was initially crimped in between the two radiopaque markers and that the bent struts were initially crimped on the balloon.The balloon is well folded and shows no signs of inflation.Review of the production documentation verified that the instruments were manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.During final inspection, every stent system undergoes visual inspection to ensure correct stent 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 of the device being subject to this complaint, no material or manufacturing related root cause could be determined.The inner diameter of the nipro guideplus ii st extension catheter is 1.33 mm and does therefore not meet the requirements specified in the orsiro ifu (= 0.056 inch, 1.42 mm).The root cause for the complaint event is therefore most likely related to the extension catheter which was used in the intervention.

Event Description

The orsiro drug-eluting stent system was selected for use.The physician intended to treat a severely calcified lesion (90 percent stenosis degree) in a mildly tortuous part of the lad, number 6.It is unknown if the target lesion was predilated.By use of a nipro guideplus ii st extension catheter the complaint instrument was introduced into the patients body.The complaint instrument could not pass the ostium of the nipro guideplus ii st and was withdrawn.Another des was used to finalize the intervention.

• Brand Name: ORSIRO 3.0/40
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 11087740
• MDR Text Key: 224252436
• Report Number: 1028232-2020-05684
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P170030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/23/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2022
• Device Model Number: 391241
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 12192042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2020
• Initial Date FDA Received: 12/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1