MAUDE Adverse Event Report: AV-TEMECULA-CT RX HERCULINK ELITE STENT SYSTEM

Catalog Number 1011493-18

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).User facility medwatch form #mw5081601.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.(b)(4).

Event Description

User facility medwatch received stating the following: patient was scheduled for pta of celiac artery an superior mesenteric artery.Dr stented the celiac and then we moved on the superior mesenteric.Doctor ballooned sma and the proceeded to try and stent the sma.The stent came off of the deployment balloon but remained on the wire.We were able to get the stent back to the sheath and into the tissue tract.However, we were unable to get it through the soft tissue tract so dr.Asked dr.To do a cut down on the right groin to remove the undeployed stent.Dr.Successfully was able to remove the stent and patient was transferred to icu in stable condition.The patient remained awake, alert and stable for the entire procedure and was made aware of the situation and was able to talk to the anesthesiologist and surgeon prior to being put to sleep for surgery.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Correction: device status changed from returning to not returned.The device was not returned for analysis.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 identified no other incidents from this lot.In the absence of the device being returned for analysis, a conclusive cause cannot be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

Event Description

Subsequent to the previously filed medwatch report, there was no resistance prior to the dislodgement.It was a steep turn.No additional information was provided.

• Brand Name: RX HERCULINK ELITE STENT SYSTEM
• Type of Device: STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8236262
• MDR Text Key: 132779940
• Report Number: 2024168-2019-00264
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• PMA/PMN Number: P110001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/11/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 1011493-18
• Device Lot Number: 8021361
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 01/10/2019
• Supplement Dates Manufacturer Received: 01/30/2019
• Supplement Dates FDA Received: 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 90 YR