MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG VENOVO VENOUS STENT SYSTEM

Catalog Number UNK VENOVO STENT

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 08/15/2009

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.

Event Description

It was reported that approximately three weeks post stent placement, the patient alleged multiple symptoms (neurological issue and back/leg pain).Reportedly, the patient's pain is improving post stent removal.

Manufacturer Narrative

H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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.

Event Description

It was reported that approximately three weeks post stent placement, the patient alleged multiple symptoms (neurological issue and back/leg pain).Reportedly, the patient's pain is improving post stent removal.

Manufacturer Narrative

H10: manufacturing review: a device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not available for evaluation.The journal article was published by the physician.Article contains venograms and ultrasound images taken during patient treatment.Based on the report, the stent was accurately placed without any kind of experienced deficiency.The alleged issue could not be re produced which led to an inconclusive evaluation result.In this case the pain did not resolve within 30 days when the stent was removed; the stent reportedly was perfectly placed.Two universities reportedly further investigated this issue but could not figure the pain; also, backpain was described already before procedure.A definite root cause for the reported event could not be determined based upon available information.Labeling review: in reviewing the relevant labeling for this product, it was found that the instructions for use sufficiently address the potential risk.Based on the instructions for use potential complications and adverse events such as pain may occur during use of after implantation of the venovo venous stent.A device deficiency was not reported so that a particular labeling entry corresponding to a deficiency was not identified.H10: g4.H11: h6 (conclusion).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.

Event Description

It was reported that a patient reported multiple symptoms (neurological problem and back/leg pain) approximately three weeks after stent implantation.Reportedly the stent was placed perfectly.The problem was investigated by two university hospitals, but no definite cause for the pain was found; as reported patient experienced back pain prior to surgery.It was reported that the patient's pain improved after the stent was removed.

• Brand Name: VENOVO VENOUS STENT SYSTEM
• Type of Device: VENOUS STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 10078440
• MDR Text Key: 191674624
• Report Number: 9681442-2020-00127
• Device Sequence Number: 1
• Product Code: QAN
• Combination Product (y/n): N
• PMA/PMN Number: P180037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK VENOVO STENT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/28/2020
• Initial Date FDA Received: 05/21/2020
• Supplement Dates Manufacturer Received: 08/20/2020; 10/22/2020
• Supplement Dates FDA Received: 09/01/2020; 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Weight: 81