MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PK PAPYRUS US 3.5/26; COVERED CORONARY STENT

Model Number	434900
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Cardiogenic Shock (2262); Thrombosis/Thrombus (4440)
Date of Event	04/13/2021
Type of Reportable Event	Death
Event or Problem Description
A pk papyrus covered stent system (3.5x26 mm) was selected for treatment of a type iii perforation located at the prox.Lad.A severely calcified lesion in the proximal lad was ballooned and subsequently treated with a rotablator due to the heavy calcium burden (vessel reference diameter 3.75 mm; stenosis degree 90 percent, lesion length 20 mm).According to the physician the perforation was caused as a result of the rotablator treatment.Standard rotablator equipment, including the rotawire and rotablator burr were used along with an ebu guidecatheter.In order to stop the bleeding protamine injection and balloon dilatation was performed prior to the use of the pk papyrus covered stent.The pk papyrus covered stent was successfully placed in the target lesion (prox.Lad) and the perforation was successfully sealed (applied pressure 14 atm/45 sec; no post dilatation was performed).Per physician complication was stent thrombosis following covered stent deployment, distal to the stent.Patient experienced cardiogenic shock and passed away on the table.
Additional Manufacturer Narrative
The affected pk papyrus stent system was not returned to biotronik and could therefore not be subjected to a technical investigation.The catheter laboratory report or images of the case such as angiographies 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 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 3.5/26
• 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: 11854482
• Report Number: 1028232-2021-02732
• Device Sequence Number: 3831673
• Product Code: NIV
• UDI-Device Identifier: 07640130447288
• UDI-Public: 07640130447288
• 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): 04/27/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 434900
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 08203282
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 05/20/2021
• 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: 80 YR