MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT SOLO VASCULAR STENT SYSTEM

Catalog Number EX062001L

Device Problems Break (1069); Positioning Failure (1158)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/28/2014

Event Type  malfunction  

Event Description

It was reported that during a stenting procedure of the femoral artery, the vascular stent was partially deployed when the delivery system sheath fractured during the first trigger hub and the stent could not be deployed any further.The delivery system with the partially released stent was removed without incident and another stent was successfully placed.No patient injury was reported.

Manufacturer Narrative

Although this product is not sold in the u.S., this event is being reported under 21 cfr part 803 as it involves a similar device to a pma approved device sold in the u.S.Under #p070014.The lot history records have been reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met all specifications prior to shipment.There is no indication for a manufacturing-related failure.The condition of the returned device does not match the event description provided.Although the sheat was found to be fractured, the characteristics of the defect and the condition of the device do not match the reported failure to deploy the stent inside the patient.Therefore, the reported event could not be reproduced.Potential factors that could have led or contributed to the reported event have been evaluated.Based on the sample condition, this event represents an isolated incident.As the reported event could not be reproduced, no potential causes or contributing factors could be determined.On the basis of the evaluation of the sample, the defect of the device must have been caused by the application of force not originated from a difficult vessel anatomy.No potential device-related cause was identified.Based on the information provided and the evaluation of the sample, a definite root cause for the reported event could not be determined.

• Brand Name: LIFESTENT SOLO VASCULAR STENT SYSTEM
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; karlsruhe ; GM
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 7622 7; GM 76227
• Manufacturer Contact: daniela mueller ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 2194450
• MDR Report Key: 4350938
• MDR Text Key: 5143388
• Report Number: 9681442-2014-00149
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: EX062001L
• Device Lot Number: ANYH1054
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/27/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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