MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 4/20/90; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number 430437

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 04/03/2023

Event Type  Injury  

Event Description

A pulsar-18 self-expandable stent system was selected for treatment.During deployment of the stent it was noticed that one of the radiopaque markers had become dislodged and travelled further down the artery.

Manufacturer Narrative

Additional event description the physician intended to treat a lesion in the right popliteal artery with the complaint instrument via guided antegrade right cfa puncture and by use of 5f introducer sheath.The lesion was pre-dilated with a drug eluting balloon 4 mm.However, there was a non-flow limiting dissection at the site of balloon angioplasty so the complaint instrument was chosen.The complaint instrument was positioned and the stent was released.However, after stent deployment, the physician noticed that the distal radiopaque marker had dislodged from the delivery system and eventually flowed down the proximal segment of the ata.The complaint instrument was withdrawn.The physician stated that no unusual resistance or friction was felt during device positioning or withdrawal.The radiopaque marker was left in the patients body.There was good flow of contrast medium across the stent and this foreign body.The procedure and the events were discussed and it was decided not to intervene further and start heparin infusion.The returned product was subjected to a detailed technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.The technical investigation confirmed that the device tip has detached from the inner shaft.All the shaft dimensions comply with the specification.In the as-returned state only about 5 mm of the inner shaft protruded from the stopper shaft.However, after cleaning about 16 mm of the inner shaft protruded from the stopper shaft, indicating a relative movement between the device shafts.It appears that due to this relative movement between the shafts, forces were applied to the device tip that eventually led to a detachment.The cause for this relative movement remains unresolved.Review of the production documentation verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations, no material or manufacturing related root cause was identified.The final root cause for the reported event could not be determined.

• Brand Name: PULSAR-18 T3 4/20/90
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• 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: 16779316
• MDR Text Key: 313677424
• Report Number: 1028232-2023-02037
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 07640130446359
• UDI-Public: (01)07640130446359(17)2311
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P160025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 430437
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 11202427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other