MAUDE Adverse Event Report: VASCUTEK LTD. GELSOFT PLUS; AX-BIFEM ERS REINFORCED

Model Number GELSOFT PLUS

Device Problem Hole In Material (1293)

Patient Problem No Information (3190)

Event Date 07/27/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: review of retained qc and manufacturing records carried out.Results: review of retained qc and manufacturing records showed batch manufactured to design specification.Conclusion: awaiting further information from site.

Event Description

The event was reported to vascutek as follows; during the procedure 2 holes were seen in the bifurcation and there was a leak.The holes were spotted after the anastomosis was done and the blood started to flow in the graft.The doctor applied prolene sutures.

Manufacturer Narrative

Correction: name of user corrected from dr (b)(6).Updated information conclusion - unable to confirm complaint; device not returned to manufacturer; no failure detected - the complete review of all of the retained manufacturing records including porosity testing records confirmed that the device was manufactured to specifications.No other units from the batch were available for evaluation as they had been sold.A review of similar events (i.E.Leakage at the bifurcation area of vascutek manufactured polyester based grafts including gelsoft, gelsoft plus, gelweave, gelseal variants) has detected 20 previously reported events (worldwide)in the last five calendar years.The sales data for this period determined that 155424 units have been sold worldwide within the same time period , thus providing an incidence rate of (b)(4).This rate is well within vascutek's action limits.Vascutek considers this case as closed; this issue will be tracked and trended as part of the routine complaints monitoring and reporting process.If an adverse trend develops action may be taken at that time.

Event Description

This report is being submitted as follow up #1 for mfg.Report no.9612515-2015-00021 to provide new & corrected information.

• Brand Name: GELSOFT PLUS
• Type of Device: AX-BIFEM ERS REINFORCED
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, scotland PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, scotland PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: carolyn forrest ; newmains avenue; inchinnan business park; renfrewshire, scotland PA4 9-RR ; UK PA4 9RR ; 1418125555
• MDR Report Key: 5044345
• MDR Text Key: 24650589
• Report Number: 9612515-2015-00021
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K034010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Report Date: 08/03/2015,09/30/2015

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 Expiration Date: 07/31/2017
• Device Model Number: GELSOFT PLUS
• Device Catalogue Number: 690808P
• Device Lot Number: 307520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/27/2015
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2012
• 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