MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PK PAPYRUS US 2.5/20; COVERED CORONARY STENT

Model Number	434893
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The pk papyrus covered stent system was selected for treatment of a type ii perforation in the svg-d1 branch.The device was advanced through a 7 f guide with a 6 f guideliner guide extension.Pk papyrus would not cross the lesion and was removed.It was stated that the stent seemed to be on the delivery system when it was removed.When the pk papyrus was being loaded on the wire it was noticed that the stent was missing.The field, scrub table, floor and surrounding areas were checked thoroughly, but the undeployed stent was not located.An additional pk papyrus with same size was deployed and the patient was stable when leaving the cath lab.
Additional Manufacturer Narrative
29-feb-2024 updated description.The pk papyrus covered stent system was selected for treatment of a type ii perforation occurred during ballooning in the svg-d1 branch.To stop the bleeding, balloon tamponade was performed.The complaint pk papyrus was advanced through a 7 f guide with a 6 f guideliner guide extension.Pk papyrus would not cross the lesion and was removed.It was stated that the stent seemed to be on the delivery system when it was removed.When the pk papyrus was being loaded on the wire it was noticed that the stent was missing.The field, scrub table, floor and surrounding areas were checked thoroughly, but the undeployed stent was not located.An additional pk papyrus with same size was deployed.The perforation was successfully sealed and the patient was stable when leaving the cath lab.The affected pk papyrus stent system was returned to biotronik and subjected to a detailed technical investigation.Images of the case such as angiographies could not be obtained.The provided clinical information (pk papyrus device registration form, cathlab report) and the production documentation were reviewed to establish whether a device deficiency contributed to this event.The technical investigation revealed that the balloon is well folded and shows no signs of inflation.Stent imprints were observed on the exposed balloon surface, indicating that the stent was properly crimped in between the two radiopaque markers at the time of delivery.The stent was not returned.In addition, the device shaft was found mildly kinked about 1 mm proximal to the proximal radiopaque marker and at the guide wire exit port.However, those damages have likely been caused after the reported event.Review of the production documentation confirmed that the device was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the provided documentation and the conducted investigation, no manufacturing related root cause could be identified.The treating physician rated the occurrence as no device-related complication.Pk papyrus is indicated for the treatment of acute perforations of native coronary arteries and coronary bypass grafts in vessels 2.5 to 5.0 mm in diameter.As such, this device is typically used in emergent response to a life-threatening adverse procedural event unrelated to use of the pk papyrus.
Additional Manufacturer Narrative
Corrected the initial reporter information.Reference capa# nc-24-004.The affected pk papyrus stent system was returned to biotronik and subjected to a detailed technical investigation.Images of the case such as angiographies could not be obtained.The provided clinical information (pk papyrus device registration form, cathlab report) and the production documentation were reviewed to establish whether a device deficiency contributed to this event.The technical investigation revealed that the balloon is well folded and shows no signs of inflation.Stent imprints were observed on the exposed balloon surface, indicating that the stent was properly crimped in between the two radiopaque markers at the time of delivery.The stent was not returned.In addition, the device shaft was found mildly kinked about 1 mm proximal to the proximal radiopaque marker and at the guide wire exit port.However, those damages have likely been caused after the reported event.Review of the production documentation confirmed that the device was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the provided documentation and the conducted investigation, no manufacturing related root cause could be identified.The treating physician rated the occurrence as no device-related complication.Pk papyrus is indicated for the treatment of acute perforations of native coronary arteries and coronary bypass grafts in vessels 2.5 to 5.0 mm in diameter.As such, this device is typically used in emergent response to a life-threatening adverse procedural event unrelated to use of the pk papyrus.

• Brand Name: PK PAPYRUS US 2.5/20
• Common Device Name: COVERED CORONARY 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: 18706761
• Report Number: 1028232-2024-00852
• Device Sequence Number: 18211293
• Product Code: NIV
• UDI-Device Identifier: 07640130447219
• UDI-Public: (01)07640130447219(17)2510
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: H170004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/16/2024

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: 10/01/2025
• Device Model Number: 434893
• Device Catalogue Number: 434893
• Device Lot Number: 09231033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2024
• Supplement Date Received by Manufacturer: 02/29/2024; 10/16/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 02/29/2024; 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male