MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PK PAPYRUS US 5.0/20; COVERED CORONARY STENT

Model Number	434898
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	07/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was a type iii cs/iv perforation in the prox.Lad in an unstented area due to a geographic miss while overlapping des stents.The pk papyrus covered stent system was inserted into the 6f guide catheter and resistance was experienced while coming through the guide in the subclavian area (still in the guide).The operator noted the stent appeared to start dislodging from the stent delivery system.The stent, stent delivery system, and guide catheter were all successfully removed.The patients perforation improved with complete resolution of the effusion and was subsequently discharged two days post op.
Additional Manufacturer Narrative
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 showed that balloon is well folded and shows no signs of inflation.Judging from the x-ray markers, the stent is displaced on the balloon by about 12 mm in distal direction.The stent is also severely deformed at its proximal end, i.E.Several struts are strongly bent outwards.Stent imprints on the exposed balloon surface indicate that the stent was properly crimped in between the two radiopaque markers at the time of delivery.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 both no device- and no procedure-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 5.0/20
• 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: 19917471
• Report Number: 1028232-2024-04113
• Device Sequence Number: 12790607
• Product Code: NIV
• UDI-Device Identifier: 07640130447264
• UDI-Public: (01)07640130447264(17)2408
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: H170004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/06/2024
• Device Model Number: 434898
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06226359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2022
• 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: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male