MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG UNKNOWN STENT

Model Number	EX071003CS
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 07/2022).Device pending return.
Event or Problem Description
It was reported that during a stent deployment procedure, x-ray examination revealed that the tip allegedly detached inside the patient.The patient status was unknown.
Event or Problem Description
It was reported that approximately two days post stent placement x-ray images allegedly demonstrated that the tip detached inside the patient.Reportedly, the tip was removed.The current patient status is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: it was not known which of two lots from two different products (aneu2485, (b)(6), was involved in this case.A review of manufacturing records was not performed, as additional complaints have not been reported for both lots.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, the lot history records of both lots were reviewed with special attention to the manufacturing and inspection of these products and the products were found to have met the specification prior to shipment.Investigation summary: the sample was not returned for evaluation and image was not provided for review.Based on the information available the investigation is inconclusive for tip detachment.A definite root cause for the reported event could not be determined.Labeling review: the sample was not available, it was not known what exactly broke and what was left inside patient.In addition it was not known which of two different product lots for two different products was involved.A specific labeling entry for a specific failure mode for a specific product was not performed.In general, preparation of the device, accessories to be used as well as holding and handling throughout deployment are described in the information for use.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: UNKNOWN STENT
• Common Device Name: STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12280046
• Report Number: 9681442-2021-00421
• Device Sequence Number: 4507349
• Product Code: NIP
• UDI-Device Identifier: 04049519001302
• UDI-Public: (01)04049519001302
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2021

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 Model Number: EX071003CS
• Device Catalogue Number: UNK STENT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Sex: Unknown