MAUDE Adverse Event Report: ABBOTT VASCULAR ABSOLUTE PRO VASCULAR; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number	1012532-80
Medical Device Problem Codes	Stretched (1601); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition periodna.
Event or Problem Description
It was reported that the procedure was to treat a non-calcified, mildly tortuous common iliac artery that was 75% stenosed.During deployment of a 10x80mm absolute pro self-expanding stent, the delivery system was attempted to be pulled back a little to re-position the stent.However, the stent became stretched at 10cm as well as the cells of the stent implant.It was noted that the stent was implanted at the target lesion as well as in healthy tissue.A 7.0x40mm absolute pro stent was additionally deployed in the stretched stent to complete the procedure.There were no adverse patient sequela reported in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Exemption number e2019001.A visual and functional analysis were performed on the returned device.The reported difficulties were not confirmed as the stent was already deployed and remains in the patient.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history revealed no indication to suggest a lot specific product issue.The investigation determined that the reported difficulties were related to procedural circumstances.The difficulties encountered were the result of attempting to re-position the stent during deployment by pulling back the delivery system.As a result, the stent stretched and partially deployed into healthy tissue.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.(b)(4).
Event or Problem Description
It was reported that the procedure was to treat a non-calcified, mildly tortuous common iliac artery that was 75% stenosed.During deployment of a 10x80mm absolute pro self-expanding stent, the delivery system was attempted to be pulled back a little to re-position the stent.However, the stent became stretched at 10cm as well as the cells of the stent implant.It was noted that the stent was implanted at the target lesion as well as in healthy tissue.A 7.0x40mm absolute pro stent was additionally deployed in the stretched stent to complete the procedure.There were no adverse patient sequela reported in the procedure.No additional information was provided.

• Brand Name: ABSOLUTE PRO VASCULAR
• Common Device Name: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8800646
• Report Number: 2024168-2019-10127
• Device Sequence Number: 2839119
• Product Code: NIP
• UDI-Device Identifier: 08717648175862
• UDI-Public: 08717648175862
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2019

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 Expiration Date: 03/31/2021
• Device Catalogue Number: 1012532-80
• Device Lot Number: 8040661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 09/14/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 10/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention