MAUDE Adverse Event Report: AV-TEMECULA-CT RX HERCULINK 14 STENT SYSTEM

Catalog Number UNKNOWN HERCULINK

Device Problems Migration or Expulsion of Device (1395); Difficult To Position (1467); Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis and the stent remains in the patient anatomy.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat a heavily tortuous and concentric superior mesenteric artery that was 90% stenosed.The patient presented with an aneurysmal superior mesenteric artery.A 6.5 x 15 mm herculink balloon expandable stent was used and met initial resistance.Therefore, the stent delivery system was removed along an unspecified guide wire; however, the stent dislodged from the stent delivery balloon and migrated towards the lower extremity of the patient leg.It was thought that the stent was inside an unspecified introducer sheath; however, it was not found anywhere under fluoroscopy.The stent was therefore not retrieved.Then a 3.5 mm trek balloon dilatation catheter was used for pre-dilatation and another 6.5 x 15 mm herculink balloon expandable stent was used to successfully complete the procedure.The patient was discharged from the hospital on (b)(6) 2018.There was no adverse patient sequela reported.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the part number was not provided.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: RX HERCULINK 14 STENT SYSTEM
• Type of Device: STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7290861
• MDR Text Key: 100755273
• Report Number: 2024168-2018-01331
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 00117107101261
• UDI-Public: 0117107101261
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN HERCULINK
• Device Lot Number: 7101261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 66 YR
• Patient Weight: 59