MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PK PAPYRUS US 3.0/15; COVERED CORONARY STENT

Model Number	434888
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
After pre-dilatation of a distal stenotic right coronary vein graft lesion and bare metal stent deployment, angiographic visualization revealed a type ii perforation in distal rca.The pk papyrus covered stent was deployed followed by another post-dilatation and successful deployment of another bare metal stent.However, post angiographic visualization revealed pericardial blush in same area where the pk papyrus was deployed.Surgical intervention was required.
Additional Manufacturer Narrative
The second pkp was placed in an overlapping manner.The perforation appeared to be sealed, but the patient required surgical intervention.The information provided suggested that the treated perforation was not a device or procedure-related complication.The patient passed away one day after the treatment following two emergency surgeries.
Additional Manufacturer Narrative
The second pkp was placed in an overlapping manner.The perforation appeared to be sealed, but the patient required surgical intervention.The information provided suggested that the treated perforation was not a device or procedure-related complication.The patient passed away one day after the treatment following two emergency surgeries.The affected pk papyrus stent system was not returned to biotronik and could therefore not be subjected to a technical investigation.Six manually recorded images of the angiography recordings with suboptimal image quality were provided.The individual images show the following sequences: pkp deployment, vessel appears sealed, perforation persists, deployment of second pkp, final image no post dilatation of pkp appears sealed and post dilatation of pkp.Review of the product release documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections during which a 100 percent control of the stent cover is performed.Based on the provided documentation and the conducted review no device deficiency or manufacturing related root cause for the reported potentially insufficient sealing of the perforation could be identified.The infor-mation provided in the pk papyrus device registration form stated that there was no device or 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 3.0/15
• 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: 12656354
• Report Number: 1028232-2021-05779
• Device Sequence Number: 4479966
• Product Code: NIV
• UDI-Device Identifier: 07640130447165
• UDI-Public: 07640130447165
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2021

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: 10/31/2021
• Device Model Number: 434888
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10194682
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2021
• Supplement Date Received by Manufacturer: 11/11/2021; 01/26/2022
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 11/11/2021; 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2019
• 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: Unknown