MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PK PAPYRUS US 4.5/26; COVERED CORONARY STENT

Model Number	434902
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Cardiogenic Shock (2262)
Date of Event	05/07/2021
Type of Reportable Event	Death
Event or Problem Description
The pk papyrus covered stent system was selected for treatment of a type iii cs/iv perforation of the ostial/proximal lcx.The mechanism of the perforation, its length and the reference vessel diameter were not reported.The perforation was initially treated with a balloon dilation in order to stop the bleeding.Afterwards the affected pkp was chosen to seal the perforation, but it got caught at a calcification and dislodged.An attempt to retrieve the stent was not successful.In the further course of the procedure the patient was hemodynamically instable, with pericardial tamponade, persisting cardiogenic shock.Patient expired due to cardiac arrest.Outcome was rated as procedure related complication, not device related.
Additional Manufacturer Narrative
The affected pk papyrus stent system was not returned to biotronik and could therefore not be subjected to a technical investigation.Images of the case such as angiographies or the cathlab report could also not be obtained.The provided clinical information (pk papyrus device registration form) was insufficient to establish whether a device deficiency contributed to this event.However, review of the product release 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 review no device deficiency or manufacturing related root cause could be identified.The treating physician rated the outcome as not device related but 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.
Event or Problem Description
The pk papyrus covered stent system was selected for treatment of a type iii cs/iv perforation of the ostial/proximal lcx.The mechanism of the perforation, its length and the reference vessel diameter were not reported.The perforation was initially treated with a balloon dilation in order to stop the bleeding.Afterwards the affected pkp was chosen to seal the perforation, but it got caught at a calcification and dislodged.An attempt to retrieve the stent was not successful.In the further course of the procedure the patient was hemodynamically unstable, with pericardial tamponade, persisting cardiogenic shock.Patient expired due to cardiac arrest.Outcome was rated as procedure related complication, not device related.

• Brand Name: PK PAPYRUS US 4.5/26
• Common Device Name: COVERED CORONARY STENT
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 11889544
• Report Number: 1028232-2021-02878
• Device Sequence Number: 1390247
• Product Code: NIV
• UDI-Device Identifier: 07640130447301
• UDI-Public: 07640130447301
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: H170004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2021

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: 09/30/2021
• Device Model Number: 434902
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 09192039
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 64 YR