MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 6/100/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430502
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 stent system was chosen for treatment of the sfa.During deployment only 1/3 of the stent could be released.Finally, a balloon was used to place the stent in the artery.
Additional Manufacturer Narrative
The returned instrument 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 the reported event.The technical investigation revealed that the retractable shaft has separated from the bushing which is connected to the pull wire being intended to release the stent.This most likely occurred during intervention when it was attempted to release the stent.Scanning electron microscope analysis was done and revealed a small amount of remaining glue at the bushing of the complaint instrument compared to the bushing of six reference instruments.This finding indicates that that the root cause for the complaint event is most likely related to the manufacturing process of a sub assembly manufactured by a supplier.The stent has been released in the patient body and was not returned for analysis.To prevent recurrence the respective internal departments were informed about this case and we are reviewing our quality systems processes.The supplier of the affected sub assembly was informed about the complaint.

• Brand Name: PULSAR-18 T3 6/100/135
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 9609194
• Report Number: 1028232-2020-00332
• Device Sequence Number: 2677294
• Product Code: NIP
• UDI-Device Identifier: 07640130447004
• UDI-Public: 07640130447004
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P160025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 430502
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 09197100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Initial Date Received by Manufacturer: 01/20/2020
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 01/20/2020
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1