MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. DUAL HOLDER S/M - PVF-M SINGLE USE ACCESSORY KIT; TISSUE HEART VALVES ACCESSORIES

Model Number N/A

Device Problem Difficult or Delayed Separation (4044)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/26/2019

Event Type  Injury  

Manufacturer Narrative

On 10 october 2019, the manufacturer received the prosthesis pvf-m, returned in generally good conditions.The returned accessories included: a s/m dual collapser (fo54689), a s/m dual holder and a smart clip.Only the dual holder pertaining to the second attempt was received.The dual collapser and the smart clip were received in general good conditions.The dual holder had the blue piston (sheath) stuck in the axial open position and slighlty rotated along the opening direction of the holder knob.The holder plastic tube (holder cylinder) was shifted forward (no longer against the blue piston).The silicone capote was slightly twisted.Further investigation is ongoing.

Event Description

On (b)(6) 2019, a pvf-m implant attempt occurred.The valve was reportedly prepared as usual practice.After the release of the inflow, the outflow part was could not be released as difficulties were reported in pulling back the dual holder shaft.A new dual holder was used with the same valve, but the same problem was encountered.Therefore, a further new dual holder and a new valve were used; it was possible to release the outflow this time, but with much more pulling force than normal.No specific concerns were reported for the valve and for the third dual-holder used.Despite the prolonged procedural time (approx.30 min of cross-clamp time and 35 min of bypass time were added), the patient remained stable during the procedure, with a good outcome after surgery.

Manufacturer Narrative

The visual inspection and collapsing replication performed on the returned prosthesis did not highlight elements of non-conformities, according to the specifications.The dimensional analysis performed on the returned dual holder, after having carefully disassembled each component, confirmed the conformity to the specification.A simulated use on a demo dual holder s/m was performed, in order to attempt to replicate the reported event.The results of the simulations showed a result quite in accordance with the reported event and congruent with some of the observed features on the returned dual holder.Based on the analysis conducted on the returned material and the simulations, it is not possible to reach to an exhaustive conclusion for the reported event.Nevertheless, it is possible to speculate about a possible sequence of maneuvers leading to a result congruent with the description reported in the case history and the features observed on the returned material.Ultimately, the root cause of the reported event remains unknown.

• Brand Name: DUAL HOLDER S/M - PVF-M SINGLE USE ACCESSORY KIT
• Type of Device: TISSUE HEART VALVES ACCESSORIES
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 9242449
• MDR Text Key: 171562163
• Report Number: 3005687633-2019-00251
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ICV1242
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 70